Study of Surzebiclimab (BGB-A425) and Alcestobart (LBL-007) in Combination With Tislelizumab in Advanced Solid Tumors

NCT03744468 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: BGB-900-102U1111-1278-00272022-500694-14
• Study Type: interventional
• Target: 147
• Locations: 6 countries
• Sites: 40

Brief Summary

This was an open-label, multicenter, nonrandomized Phase 1 and 2 clinical trial evaluating various combinations of surzebiclimab (BGB-A425) and/or alcestobart (LBL-007) with tislelizumab.

Conditions

Locally Advanced or Metastatic Solid Tumors for Phase 1, Dose Escalation and Phase 2 Safety Lead-in; HNSCC for Phase 2 Dose Expansion; NSCLC for Phase 2 Dose Expansion

Outcome Measures

Primary Outcomes (8)

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

  An Adverse Event (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. 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. An 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. 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 last dose of study drug (maximum treatment duration: up to 32.7 months)

• Phase 1: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of Surzebiclimab in Combination With Tislelizumab

  The MAD was defined as the highest dose administered, where all dose levels were tolerated during dose escalation. The MTD was not reached in Phase 1, therefore the MAD was reported.

  Up to 28 days

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

  The RP2D or recommended dose for expansion of the combination treatment was determined based upon the MTD or MAD, and also considered the long-term tolerability, PK, efficacy, and any other relevant data as available.

  Up to 28 days

• Phase 2 (Safety Lead-In): Number of Participants With TEAEs and SAEs

  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. 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. An 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. Severity of AEs was assessed according to 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 last dose of study drug (maximum duration of treatment: up to 19.6 months in Cohort A and up to 21.5 months in Cohort B)

• Phase 2 (Safety Lead-In): MTD or MAD of Alcestobart in Combination With Tislelizumab

  The MAD was defined as the highest dose administered, where all dose levels were tolerated during dose escalation. The MTD was not reached in Phase 2, therefore the MAD was reported.

  Up to 21 days

• Phase 2 (Safety Lead-In): MTD or MAD of Alcestobart in Combination With Surzebiclimab and Tislelizumab

  The MAD was defined as the highest dose administered, where all dose levels were tolerated during dose escalation. The MTD was not reached in Phase 2, therefore the MAD was reported.

  Up to 21 days

• Phase 2 (Safety Lead-In): RP2D of Alcestobart in Combination With Surzebiclimab and Tislelizumab

  The RP2D or recommended dose for expansion of the combination treatment was determined based upon the MTD or MAD, and also considered the long-term tolerability, PK, efficacy, and any other relevant data as available.

  Up to 21 days

• Phase 2 (Dose Expansion): Overall Response Rate (ORR)

  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 on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to11.3 months, Cohort 5: up to 15.9 months

Secondary Outcomes (39)

• Phase 1: Overall Response Rate (ORR)

  Maximum time on study: up to 57.5 months

• Phase 2 (Safety Lead- In): Overall Response Rate (ORR)

  Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 months

• Phase 1: Disease Control Rate (DCR)

  Maximum time on study: up to 57.5 months

• Phase 2 (Safety Lead-In): Disease Control Rate (DCR)

  Maximum time on study: Cohort A: up to 22.1 months; Cohort B: up to 21.5 months

• Phase 2 (Dose Expansion): Disease Control Rate (DCR)

  Maximum time on study: Cohort 1: up to 31.3 months, Cohort 2: up to 32.0 months, Cohort 4: up to 11.3 months, Cohort 5: up to 15.9 months

Study Arms (20)

Phase 1 (Dose Escalation): Surzebiclimab 2 Milligrams (mg) + Tislelizumab

EXPERIMENTAL

Participants received surzebiclimab 2 mg intravenous (IV) infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 2 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Drug: Surzebiclimab; Drug: Tislelizumab

Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab

EXPERIMENTAL

Participants received surzebiclimab 6 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 6 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Drug: Surzebiclimab; Drug: Tislelizumab

Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab

EXPERIMENTAL

Participants received surzebiclimab 20 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 20 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Drug: Surzebiclimab; Drug: Tislelizumab

Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab

EXPERIMENTAL

Participants received surzebiclimab 60 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 60 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Drug: Surzebiclimab; Drug: Tislelizumab

Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab

EXPERIMENTAL

Participants received surzebiclimab 200 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 200 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Drug: Surzebiclimab; Drug: Tislelizumab

Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab

EXPERIMENTAL

Participants received surzebiclimab 400 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter, until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Drug: Surzebiclimab; Drug: Tislelizumab

Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab

EXPERIMENTAL

Participants received surzebiclimab 800 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 800 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Drug: Surzebiclimab; Drug: Tislelizumab

Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab

EXPERIMENTAL

Participants received surzebiclimab 1600 mg IV infusion on day 1 of each cycle. In the first cycle, tislelizumab 200 mg was administered intravenously on Day 8. If tolerated, participants received surzebiclimab 400 mg along with tislelizumab sequentially on Day 29 and every 21 days (i.e., once every 21 days) thereafter until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Cycle 1 consisted of 28 days, and each cycle from Cycle 2 onwards consisted of 21 days.

Drug: Surzebiclimab; Drug: Tislelizumab

Phase 1 (Dose Escalation): Surzebiclimab 60 mg

EXPERIMENTAL

Participants received one dose of surzebiclimab 60 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.

Drug: Surzebiclimab

Phase 1 (Dose Escalation): Surzebiclimab 1600 mg

EXPERIMENTAL

Participants received one dose of surzebiclimab 1600 mg IV infusion on Day 1 of Cycle 1 and discontinued the study treatment. Cycle 1 consisted of 28 days.

Drug: Surzebiclimab

Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab

EXPERIMENTAL

Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Drug: Tislelizumab; Drug: Alcestobart

Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab

EXPERIMENTAL

Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Drug: Tislelizumab; Drug: Alcestobart

Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab

EXPERIMENTAL

Participants received alcestobart 1200 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Drug: Tislelizumab; Drug: Alcestobart

Phase 2 (Safety Lead-In): Cohort B: Alcestobart 300 mg + BGB-A425 + Tislelizumab

EXPERIMENTAL

Participants received alcestobart 300 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Drug: Tislelizumab; Drug: Alcestobart

Phase 2 (Safety Lead-In): Cohort B: Alcestobart 600 mg + Surzebiclimab + Tislelizumab

EXPERIMENTAL

Participants received alcestobart 600 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Drug: Surzebiclimab; Drug: Tislelizumab; Drug: Alcestobart

Phase 2 (Safety Lead-In): Cohort B: Alcestobart 900 mg + Surzebiclimab + Tislelizumab

EXPERIMENTAL

Participants received alcestobart 900 mg IV infusion on day 1 of each cycle along with surzebiclimab 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Drug: Surzebiclimab; Drug: Tislelizumab; Drug: Alcestobart

Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab

EXPERIMENTAL

Participants with head and neck squamous cell carcinoma (HNSCC) received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Drug: Surzebiclimab; Drug: Tislelizumab

Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab

EXPERIMENTAL

Participants with non-small cell lung cancer (NSCLC) received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Drug: Surzebiclimab; Drug: Tislelizumab

Phase 2 (Dose Expansion): Cohort 4: HNSCC Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab

EXPERIMENTAL

Participants with HNSCC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Drug: Surzebiclimab; Drug: Tislelizumab; Drug: Alcestobart

Phase 2 (Dose Expansion): Cohort 5: NSCLC: Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab

EXPERIMENTAL

Participants with NSCLC received surzebiclimab 600 mg IV infusion on day 1 of each cycle along with alcestobart 600 mg IV and tislelizumab 200 mg IV once every 21 days until they were no longer considered to receive clinical benefit, unacceptable toxicity, or withdrawal of informed consent. Each cycle consisted of 21 days.

Drug: Surzebiclimab; Drug: Tislelizumab; Drug: Alcestobart

Interventions

Tislelizumab DRUG

Humanized, IgG4-variant monoclonal antibody against PD-1

Also known as: BGB-A317

Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab; Phase 1 (Dose Escalation): Surzebiclimab 2 Milligrams (mg) + Tislelizumab; Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab; Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab; Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab; Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab; Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab; Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab; Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab; Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab; Phase 2 (Dose Expansion): Cohort 4: HNSCC Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab; Phase 2 (Dose Expansion): Cohort 5: NSCLC: Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab; Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab; Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab; Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab; Phase 2 (Safety Lead-In): Cohort B: Alcestobart 300 mg + BGB-A425 + Tislelizumab; Phase 2 (Safety Lead-In): Cohort B: Alcestobart 600 mg + Surzebiclimab + Tislelizumab; Phase 2 (Safety Lead-In): Cohort B: Alcestobart 900 mg + Surzebiclimab + Tislelizumab

Surzebiclimab DRUG

Humanized immunoglobulin G1 (IgG1)-variant monoclonal antibody against TIM-3

Also known as: BGB-A425

Phase 1 (Dose Escalation): Surzebiclimab 1600 mg; Phase 1 (Dose Escalation): Surzebiclimab 1600 mg + Tislelizumab; Phase 1 (Dose Escalation): Surzebiclimab 2 Milligrams (mg) + Tislelizumab; Phase 1 (Dose Escalation): Surzebiclimab 20 mg + Tislelizumab; Phase 1 (Dose Escalation): Surzebiclimab 200 mg + Tislelizumab; Phase 1 (Dose Escalation): Surzebiclimab 400 mg + Tislelizumab; Phase 1 (Dose Escalation): Surzebiclimab 6 mg + Tislelizumab; Phase 1 (Dose Escalation): Surzebiclimab 60 mg; Phase 1 (Dose Escalation): Surzebiclimab 60 mg + Tislelizumab; Phase 1 (Dose Escalation): Surzebiclimab 800 mg + Tislelizumab; Phase 2 (Dose Expansion): Cohort 1: HNSCC: Surzebiclimab 600 mg + Tislelizumab; Phase 2 (Dose Expansion): Cohort 2: NSCLC: Surzebiclimab 600 mg + Tislelizumab; Phase 2 (Dose Expansion): Cohort 4: HNSCC Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab; Phase 2 (Dose Expansion): Cohort 5: NSCLC: Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab; Phase 2 (Safety Lead-In): Cohort B: Alcestobart 600 mg + Surzebiclimab + Tislelizumab; Phase 2 (Safety Lead-In): Cohort B: Alcestobart 900 mg + Surzebiclimab + Tislelizumab

Alcestobart DRUG

Human anti LAG-3 antibody

Also known as: LBL-007

Phase 2 (Dose Expansion): Cohort 4: HNSCC Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab; Phase 2 (Dose Expansion): Cohort 5: NSCLC: Surzebiclimab 600 mg + Alcestobart 600 mg + Tislelizumab; Phase 2 (Safety Lead-In): Cohort A: Alcestobart 1200 mg + Tislelizumab; Phase 2 (Safety Lead-In): Cohort A: Alcestobart 300 mg + Tislelizumab; Phase 2 (Safety Lead-In): Cohort A: Alcestobart 600 mg + Tislelizumab; Phase 2 (Safety Lead-In): Cohort B: Alcestobart 300 mg + BGB-A425 + Tislelizumab; Phase 2 (Safety Lead-In): Cohort B: Alcestobart 600 mg + Surzebiclimab + Tislelizumab; Phase 2 (Safety Lead-In): Cohort B: Alcestobart 900 mg + Surzebiclimab + Tislelizumab

Eligibility Criteria

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

You may qualify if:

• Participants were aged \>=18 years.
• Adequate organ function.
• Eastern Cooperative Oncology Group (ECOG) performance status \<=1.
• Must have been able to provide a recently obtained archival tumor tissue or fresh tumor biopsy.
• The phase 1 dose escalation and phase 2 safety lead-in enrolled participants with histologically/cytologically confirmed advanced/metastatic solid tumors who had previously received standard systemic therapy per local guidelines, unless it was not available, not tolerated or determined not appropriate based on investigators judgement, and had at least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
• The phase 2 dose expansion enrolled participants with recurrent/metastatic HNSCC (Cohorts 1 and 4) and advanced/metastatic NSCLC (Cohorts 2 and 5), with disease progression that occurred \>=10 weeks from the initiation of anti-PD-1/PD-L1 treatment for locally advanced or metastatic disease and had at least 1 measurable lesion outside of the central nervous system per RECIST v1.1.

You may not qualify if:

• A history of severe hypersensitivity reactions to other monoclonal antibodies.
• Active autoimmune disease or a history of autoimmune diseases that might relapse or a history of life-threatening toxicity related to prior immune therapy.
• Any condition that required systemic treatment with either corticosteroids or other immunosuppressive medication \<=14 days before administration of study drug.
• A history of interstitial lung disease, noninfectious pneumonitis or uncontrolled lung diseases.
• Prior therapy targeting TIM-3 and/or LAG-3.
• The phase 2 dose expansion NSCLC cohorts excluded participants with known sensitizing epidermal growth factor receptor (EGFR) mutation, v-raf murine sarcoma viral oncogene homolog B1 (BRAF) mutation, anaplastic lymphoma kinase (ALK) fusion, or c-ros oncogene 1 (ROS1) fusion.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (40)

Chao Family Comprehensive Cancer Center

Orange, California, 92868-3201, United States

Location

University of Colorado Cancer Center

Aurora, Colorado, 80045-2517, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637-1443, United States

Location

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536-7001, United States

Location

Weill Cornell Medical College Newyork Presbyterian Hospital

New York, New York, 10065-4870, United States

Location

University of North Carolina At Chapel Hill

Chapel Hill, North Carolina, 27514-4220, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111-2434, United States

Location

The University of Texas Md Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Ut Health San Antonio Mays Cancer Center

San Antonio, Texas, 78229-4427, United States

Location

University of Virginia

Charlottesville, Virginia, 22908-0817, United States

Location

Schar Cancer Institute

Fairfax, Virginia, 22031-4867, United States

Location

Sydney Southwest Private Hospital

Liverpool, New South Wales, NSW 2170, Australia

Location

Sunshine Coast Hospital and Health Service

Birtinya, Queensland, QLD 4575, Australia

Location

Gold Coast University Hospital

Southport, Queensland, QLD 4215, Australia

Location

Lyell McEwin Hospital

Elizabeth Vale, South Australia, SA 5112, Australia

Location

Calvary North Adelaide Hospital

North Adelaide, South Australia, SA 5006, Australia

Location

Box Hill Hospital

Box Hill, Victoria, VIC 3128, Australia

Location

Cabrini Research and Education Institute

Malvern, Victoria, VIC 3144, Australia

Location

Peter Maccallum Cancer Centre

Melbourne, Victoria, VIC 3000, Australia

Location

Western Health Sunshine Hospital

St Albans, Victoria, VIC 3021, Australia

Location

Hollywood Private Hospital

Nedlands, Western Australia, WA 6009, Australia

Location

Linear Clinical Research

Nedlands, Western Australia, WA 6009, Australia

Location

Centre de Lutte Contre Le Cancer Institut Bergonie

Bordeaux, 33000, France

Location

Centre de Lutte Contre Le Cancer Francois Baclesse

Caen, 14000, France

Location

Institut Curie Paris

Paris, 75005, France

Location

Irccs Azienda Ospedaliero Universitaria Bologna

Bologna, 40138, Italy

Location

Fondazione Irccs Istituto Nazionale Dei Tumori

Milan, 20133, Italy

Location

Istituto Di Candiolo Irccs

Torino, 10060, Italy

Location

Chungbuk National University Hospital

SeowonGu CheongjuSi, Chungcheongbukdo, 28644, South Korea

Location

The Catholic University of Korea, St Vincents Hospital

PaldalGu SuwonSi, Gyeonggi-do, 16247, South Korea

Location

Gachon University Gil Medical Center

NamdongGu, Incheon Gwang'Yeogsi, 21565, South Korea

Location

The Catholic University of Korea, Seoul St Marys Hospital

SeochoGu, Seoul Teugbyeolsi, 06591, South Korea

Location

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

Location

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

Location

Ulsan University Hospital

Donggu, Ulsan Gwang'Yeogsi, 44033, South Korea

Location

Ajou University Hospital

Suwon, 16499, South Korea

Location

Institut Catala Doncologia

Barcelona, 08908, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario Hm Madrid Sanchinarro

Madrid, 28050, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

MeSH Terms

Interventions

tislelizumab

Limitations and Caveats

Based on the interim analysis of Cohorts 1, 2, 4, 5 in dose expansion, sponsor decided not to further investigate the combinations in RCC and to not investigate alcestobart (LBL-007), double or triple treatment combination in PD-1 resistant NSCLC and HNSCC. Hence, Phase 2 (Dose Expansion) Cohorts 3, 6 and 7 were planned, but not initiated based on sponsor's decision.

Results Point of Contact

• Title: Study Director
• Organization: BeiGene

clinicaltrials@beigene.com

18778285568

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
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This was an open-label, multicenter, nonrandomized Phase 1 and Phase 2 clinical trial. Phase 1 determined the recommended phase 2 dose (RP2D) for the combination of surzebiclimab, and tislelizumab. Phase 2 safety lead-in determined the RP2D for the combination of alcestobart and tislelizumab with or without surzebiclimab. Phase 2 dose expansion continued to evaluate the safety but also focus on the efficacy of the double or triplet treatment combination in select tumor types.

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: November 16, 2018
• Study Start: November 13, 2018
• Primary Completion: February 6, 2025
• Study Completion: February 6, 2025
• Last Updated: April 2, 2026
• Results First Posted: April 2, 2026

Record last verified: 2026-03

Data Sharing

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

Locations

AU (11); ES (4); IT (3); KR (8); US (11); FR (3)