Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors

NCT04047862 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: BGB-900-105AdvanTIG-105CTR20202608
• Study Type: interventional
• Target: 446
• Locations: 6 countries
• Sites: 65

Brief Summary

The primary objectives of this study were: to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1. Primary objective of Phase 1b was to assess overall response rate (ORR) determined by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 for patients in each dose-expansion cohort.

Conditions

Locally Advanced and Metastatic Solid Tumors

Keywords

BGB-A1217; Anti-TIGIT antibody; Tislelizumab; anti-PD-1 antibody; Ociperlimab

Outcome Measures

Primary Outcomes (5)

• Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

  An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Treatment-emergent adverse event (TEAE) was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. Severity of AEs was assessed according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.

  Up to 30 days after the last dose of study interventions (up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])

• Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)

  The DLTs were defined as high grade (Grade 3 or 4) non-hematologic toxicities (that is, \>= Grade 4 toxicity; Grade 3 toxicity that is clinically significant and does not resolve to baseline or \<=Grade 1 within 7 days of initiating optimal supportive care), or hematologic toxicities (Grade 4 neutropenia lasting \> 7 days; \>=Grade 3 febrile neutropenia; Grade 3 thrombocytopenia with clinically significant bleeding; Grade 4 thrombocytopenia lasting \> 7 days; \>=Grade 4 anemia occurring during the DLT assessment window and considered by the investigator to be related to ociperlimab and/or tislelizumab.

  Up to 28 days (for Dose escalation cohorts) and up to 21 days (for Dose verification cohorts)

• Phase 1: Maximum Administered Dose (MAD) of Ociperlimab in Combination With Tislelizumab

  MAD was defined as the highest dose of ociperlimab administered.

  Up to 28 days (Dose escalation cohort)

• Phase 1: Recommended Phase 2 Dose (RP2D) of Ociperlimab in Combination With Tislelizumab

  RP2D of Ociperlimab in combination with Tislelizumab 200 mg was determined primarily from the safety, tolerability, and pharmacokinetic (PK) data of dose escalation cohorts.

  up to 28 days (Dose escalation cohorts)

• Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1

  ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

  Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)

Secondary Outcomes (21)

• Phase 1: ORR as Per RECIST v.1.1

  Maximum time duration on study: up to 35.7 months (Dose escalation cohorts) and up to 13.3 months (Dose verification cohorts)

• Phase 1: Duration of Response (DOR) as Per RECIST v.1.1

  From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])

• Phase 1: Disease Control Rate (DCR) as Per RECIST v.1.1

  From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])

• Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab

  C1D1 (pre and post dose; 24 hours (h) 72h, 168h and 336 h post-dose), C2D1 (pre- and post-dose), C5D1 (pre and post dose,168h and 336 h post-dose), C6D1 (pre and post-dose), pre-dose on C9D1,C13D1,C17D1,C25D1 (Cycle 1= 28 days; Cycle 2 onwards= 21 days)

• Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab

  Cycle 1, Day 8 (pre-dose), Cycle 1, Day 8 (post-dose), Cycle 2, Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose), Cycle 5 Day 1 (post-dose), pre-dose of Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 25 Day 1 (each cycle = 21 days)

Study Arms (19)

Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg

EXPERIMENTAL

Participants received ociperlimab 50 milligrams (mg) intravenous (IV) infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (that is, \[i.e.\], every 3 weeks \[Q3W\]) until disease progression, adverse events (AEs), participant withdrew consent, lost to follow-up or death, whichever came first.

Drug: Ociperlimab; Drug: Tislelizumab

Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg

EXPERIMENTAL

Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.

Drug: Ociperlimab; Drug: Tislelizumab

Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg

EXPERIMENTAL

Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.

Drug: Ociperlimab; Drug: Tislelizumab

Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg

EXPERIMENTAL

Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.

Drug: Ociperlimab; Drug: Tislelizumab

Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg

EXPERIMENTAL

Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.

Drug: Ociperlimab; Drug: Tislelizumab

Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg)

EXPERIMENTAL

Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.

Drug: Ociperlimab

Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg)

EXPERIMENTAL

Participants received ociperlimab 900 mg as IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent.

Drug: Ociperlimab; Drug: Tislelizumab

Phase 1b: Dose Expansion: Cohort 1

EXPERIMENTAL

Participants with metastatic squamous non-small cell lung cancer (NSCLC) received treatment with ociperlimab 900 mg IV infusion along with tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received 4 to 6 cycles of chemotherapy with carboplatin at an area under the curve (AUC) 5 or 6 (Day 1) + paclitaxel 200 or 175 mg/m\^2 (Day 1) or nab paclitaxel 100 mg/m\^2 (Days 1, 8 and 15) Q3W p until disease progression, intolerable toxicity, or withdrawal of consent.

Drug: Ociperlimab; Drug: Tislelizumab; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: Carboplatin

Phase 1b: Dose Expansion: Cohort 2

EXPERIMENTAL

Participants with metastatic non-squamous NSCLC received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received cisplatin 75 mg/m\^2 or carboplatin (AUC 5) and pemetrexed 500 mg/m\^2 (on Day 1) Q3W for 4-6 cycles followed by ociperlimab 900 mg + tislelizumab 200 mg + pemetrexed 500 mg/m\^2 on Day 1 Q3W until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.

Drug: Ociperlimab; Drug: Tislelizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin

Phase 1b: Dose Expansion: Cohort 3

EXPERIMENTAL

Participants with metastatic NSCLC (programmed cell death protein-ligand 1 \[PD-L1\] positive, tumor cell \[TC\] \>=1%) were treated with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.

Drug: Ociperlimab; Drug: Tislelizumab

Phase 1b: Dose Expansion: Cohort 4

EXPERIMENTAL

Participants with extensive-stage small-cell lung cancer (SCLC) received treatment with ociperlimab 900 mg IV infusion, tislelizumab 200 mg IV infusion. Participants also received 4 cycles of etoposide 100 mg/m\^2 (on Days 1, 2, 3), and cisplatin 75 mg/m\^2 or carboplatin AUC 5 (Day 1) Q3W, followed by ociperlimab 900 mg (Day 1) + tislelizumab 200 mg (Day 1) Q3W until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.

Drug: Ociperlimab; Drug: Tislelizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide

Phase 1b: Dose Expansion: Cohort 5

EXPERIMENTAL

Checkpoint inhibitor (CPI)-experienced NSCLC participants received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of each 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.

Drug: Ociperlimab; Drug: Tislelizumab

Phase 1b: Dose Expansion: Cohort 6

EXPERIMENTAL

Participants with metastatic esophageal squamous cell carcinoma (ESCC) received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and 5-fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.

Drug: Ociperlimab; Drug: Tislelizumab; Drug: Paclitaxel; Drug: Cisplatin; Drug: 5fluorouracil

Phase 1b: Dose Expansion: Cohort 7

EXPERIMENTAL

Participants with metastatic esophageal adenocarcinoma (EAC) received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m\^2 (Day 1), and 5-Fluorouracil 750-800 mg/m\^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m\^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.

Drug: Ociperlimab; Drug: Tislelizumab; Drug: Paclitaxel; Drug: Cisplatin; Drug: 5fluorouracil

Phase 1b: Dose Expansion: Cohort 8

EXPERIMENTAL

Participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC; PD-L1 positive, visually estimated Combined Positive Score \[vCPS\] \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.

Drug: Ociperlimab; Drug: Tislelizumab

Phase 1b: Dose Expansion: Cohort 9

EXPERIMENTAL

Participants with unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m\^2 \[Day 1\] and capecitabine 1000 mg/m\^2 \[Day 1-14 twice daily\]), or (cisplatin 75 mg/m\^2 \[Day\], and 5-FU 750-800 mg/m\^2 \[Day 1-5\]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m\^2 twice daily (Day 1-14) Q3W until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.

Drug: Ociperlimab; Drug: Tislelizumab; Drug: Cisplatin; Drug: 5fluorouracil; Drug: Oxaliplatin; Drug: Capecitabine

Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg)

EXPERIMENTAL

articipants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.

Drug: Ociperlimab; Drug: Tislelizumab

Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)

EXPERIMENTAL

Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.

Drug: Ociperlimab; Drug: Tislelizumab

Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg)

EXPERIMENTAL

Participants with metastatic NSCLC (PD-L1 positive, TC \>= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first.

Drug: Ociperlimab; Drug: Tislelizumab

Interventions

Ociperlimab DRUG

Administered as an intravenous (IV) injection

Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg; Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg; Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg; Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg; Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg; Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg); Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg); Phase 1b: Dose Expansion: Cohort 1; Phase 1b: Dose Expansion: Cohort 2; Phase 1b: Dose Expansion: Cohort 3; Phase 1b: Dose Expansion: Cohort 4; Phase 1b: Dose Expansion: Cohort 5; Phase 1b: Dose Expansion: Cohort 6; Phase 1b: Dose Expansion: Cohort 7; Phase 1b: Dose Expansion: Cohort 8; Phase 1b: Dose Expansion: Cohort 9; Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg); Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg); Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)

Tislelizumab DRUG

Administered as an IV injection

Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg; Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg; Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg; Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg; Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg; Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg); Phase 1b: Dose Expansion: Cohort 1; Phase 1b: Dose Expansion: Cohort 2; Phase 1b: Dose Expansion: Cohort 3; Phase 1b: Dose Expansion: Cohort 4; Phase 1b: Dose Expansion: Cohort 5; Phase 1b: Dose Expansion: Cohort 6; Phase 1b: Dose Expansion: Cohort 7; Phase 1b: Dose Expansion: Cohort 8; Phase 1b: Dose Expansion: Cohort 9; Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg); Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg); Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg)

Pemetrexed DRUG

Administered in accordance with local guidelines, prescribing information/summary of product

Phase 1b: Dose Expansion: Cohort 2

Paclitaxel DRUG

Administered in accordance with local guidelines , prescribing information/summary of product

Phase 1b: Dose Expansion: Cohort 1; Phase 1b: Dose Expansion: Cohort 6; Phase 1b: Dose Expansion: Cohort 7

Nab paclitaxel DRUG

Administered in accordance with local guidelines , prescribing information/summary of product

Phase 1b: Dose Expansion: Cohort 1

Carboplatin DRUG

Administered in accordance with local guidelines , prescribing information/summary of product

Phase 1b: Dose Expansion: Cohort 1; Phase 1b: Dose Expansion: Cohort 2; Phase 1b: Dose Expansion: Cohort 4

Cisplatin DRUG

Administered in accordance with local guidelines , prescribing information/summary of product

Phase 1b: Dose Expansion: Cohort 2; Phase 1b: Dose Expansion: Cohort 4; Phase 1b: Dose Expansion: Cohort 6; Phase 1b: Dose Expansion: Cohort 7; Phase 1b: Dose Expansion: Cohort 9

Etoposide DRUG

Administered in accordance with local guidelines , prescribing information/summary of product

Phase 1b: Dose Expansion: Cohort 4

5fluorouracil DRUG

Administered in accordance with local guidelines , prescribing information/summary of product

Phase 1b: Dose Expansion: Cohort 6; Phase 1b: Dose Expansion: Cohort 7; Phase 1b: Dose Expansion: Cohort 9

Oxaliplatin DRUG

Administered in accordance with local guidelines , prescribing information/summary of product

Phase 1b: Dose Expansion: Cohort 9

Capecitabine DRUG

Administered in accordance with local guidelines , prescribing information/summary of product

Phase 1b: Dose Expansion: Cohort 9

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Had Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (\<=) 1.
• Greater than or equal to (\>=) measurable lesion per RECIST v1.1.
• Had adequate organ function.
• Phase 1- Participants with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who had previously received standard systemic therapy or for which treatment is not available, not tolerated or refused.
• Signed informed consent form (ICF) and able to comply with study requirements.
• Age \>= 18 years (or the legal age of consent) at the time the ICF was signed.
• Histologically or cytologically confirmed tumor types in the following disease cohorts:
• Cohort 1: stage IV squamous NSCLC Cohort 2: stage IV non-squamous NSCLC Cohort 3: stage IV squamous or non-squamous NSCLC with PD-L1 positive. Cohort 4: extensive-stage SCLC Cohort 5: stage IIIB, IIIC or IV NSCLC Cohort 6: stage IV ESCC Cohort 7: stage IV EAC Cohort 8: recurrent or metastatic HNSCC incurable by local therapies Cohort 9: stage IV G/GEJ adenocarcinoma. Cohort 10: stage IV squamous or non-squamous NSCLC with PD-L1 positive.
• ECOG Performance Status \<= 1
• Adequate organ function
• Were willing to use highly effective method of birth control

You may not qualify if:

• Active brain or leptomeningeal metastasis.
• Active autoimmune diseases or history of autoimmune diseases that could have relapsed.
• Had severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for patients with hepatocellular carcinoma).
• Concurrent participation in another therapeutic clinical trial.
• Received prior therapies targeting TIGIT.
• Participants with any prior therapy for recurrent/metastatic disease.
• Non-squamous NSCLC patients with sensitizing epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, and c-ros oncogene 1 (ROS1) fusion.
• Gastric cancer participants with squamous or with positive HER2 expression.
• Prior therapy with any drug specifically targeting T-cell co-stimulation or checkpoint pathways. (anti-PD(L)1 exception for Cohort 5).
• Active leptomeningeal disease or uncontrolled brain metastasis.
• Active autoimmune diseases or history of autoimmune diseases that may relapse.
• With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for participants with hepatocellular carcinoma).
• Concurrent participation in another therapeutic clinical study.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (65)

Mayo Clinic Phoenix

Phoenix, Arizona, 85254, United States

Location

Scri Florida Cancer Specialists South

Fort Myers, Florida, 33901, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Scri Florida Cancer Specialists North

St. Petersburg, Florida, 33705, United States

Location

University of Kansas Medical Center Research Institute

Kansas City, Kansas, 66160, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Tennessee Oncology, Pllc Nashville

Nashville, Tennessee, 37203, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, 2148, Australia

Location

Chris Obrien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

Pindara Private Hospital

Benowa, Queensland, 4217, Australia

Location

Icon Cancer Foundation

South Brisbane, Queensland, 4101, Australia

Location

Metro South Health, Cancer Trials Unit Division of Cancer Services Pah

Woolloongabba, Queensland, 4102, Australia

Location

Ashford Cancer Centre Research Northeast

Windsor Gardens, South Australia, 5087, Australia

Location

Royal Hobart Hospital

Hobart, Tasmania, 7000, Australia

Location

Bendigo Health

Bendigo, Victoria, 3550, Australia

Location

Monash Health

Clayton, Victoria, 3168, Australia

Location

St Vincents Hospital

Fitzroy, Victoria, 3065, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

St John of God Health Care

Subiaco, Western Australia, 6008, Australia

Location

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Beijing Tongren Hospital, Cmu

Beijing, Beijing Municipality, 100010, China

Location

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, 100050, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Beijing Luhe Hospital, Capital Medical University

Beijing, Beijing Municipality, 101149, China

Location

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

Location

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Jilin Cancer Hospital

Changchun, Jilin, 130021, China

Location

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

Weifang Peoples Hospital

Weifang, Shandong, 261000, China

Location

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Sichuan Cancer Hospital and Institute

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Nzcr Christchurch

Christchurch, 8011, New Zealand

Location

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

The Catholic University of Korea, St Vincents Hospital

Suwon, Gyeonggi-do, 16247, South Korea

Location

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, 52727, South Korea

Location

Gachon University Gil Medical Center

Incheon, Incheon Gwang'yeogsi, 21565, South Korea

Location

Severance Hospital Yonsei University Health System

Seoul, Seoul Teugbyeolsi, 03722, South Korea

Location

The Catholic University of Korea, Seoul St Marys Hospital

Seoul, Seoul Teugbyeolsi, 06591, South Korea

Location

Smg Snu Boramae Medical Center

Seoul, Seoul Teugbyeolsi, 07061, South Korea

Location

Hualien Tzu Chi Hospital

Hualien City, 970, Taiwan

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, 40201, Taiwan

Location

China Medical University Hospital

Taichung, 40447, Taiwan

Location

Veterans General Hospital Taichung

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Taipei Tzu Chi Hospital

Taipei, 231405, Taiwan

Location

Linkou Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

Location

Related Publications (1)

• Frentzas S, Kao S, Gao R, Zheng H, Rizwan A, Budha N, de la Hoz Pedroza L, Tan W, Meniawy T. AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors. J Immunother Cancer. 2023 Oct;11(10):e005829. doi: 10.1136/jitc-2022-005829.

  PMID: 37857528 RESULT

MeSH Terms

Interventions

tislelizumab; Pemetrexed; Paclitaxel; Taxes; Carboplatin; Cisplatin; Etoposide; Fluorouracil; Oxaliplatin; Capecitabine

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

+1-877-828-5568

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 7, 2019
• Study Start: August 15, 2019
• Primary Completion: August 7, 2024
• Study Completion: August 7, 2024
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

AU (12); TW (9); US (11); CN (23); NZ (2); KR (8)