Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

NCT04198766 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: Ph 1 Ph 2 INBRX-106KEYNOTE A99 and MK-3475-A99
• Study Type: interventional
• Target: 296
• Locations: 4 countries
• Sites: 42

Brief Summary

This is a Phase 1/2, open-label, non-randomized, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA.

Conditions

Gastric Cancer; Renal Cell Carcinoma; Urothelial Carcinoma; Non-Small Cell Lung Cancer; Head and Neck Cancer; Melanoma; Solid Tumor

Keywords

Phase 1 and Phase 2; Phase 1 and Phase 2 Clinical Trial; Solid Tumors; Head and Neck Cancer; Lung Cancer; Non-Small Cell Lung Cancer; OX40 receptor agonist; PD-L1 positive; Pembrolizumab; Keytruda; Chemotherapy; Immunotherapy; HNSCC; Oropharyngeal cancer; Hypopharyngeal cancer; Oral cancer; INBRX-106; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Head and Neck Neoplasms; Neoplasms by Site; Carcinoma; Carcinoma, Squamous Cell; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Immunological; Antineoplastic Agents; Squamous Cell Carcinoma of Head and Neck; NSCLC

Outcome Measures

Primary Outcomes (5)

• Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab

  Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0

  ~2 years

• Severity of adverse events of INBRX-106 as single agent and in combination with pembrolizumab

  Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0

  ~2 years

• MTD and/or RP2D of INBRX-106 as single agent and in combination with pembrolizumab

  Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-106 and INBRX-106 in combination with pembrolizumab

  ~2 years

• Antitumor activity of INBRX-106 in combination with pembrolizumab in expansion cohorts

  Tumor response will be determined by immune Response Evaluation Criteria in Solid Tumors (iRECIST).

  ~2 years

• Frequency and severity of adverse events of INBRX-106 in combination with pembrolizumab and chemotherapy in adults with locally advanced or metastatic NSCLC

  Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0

  ~2 years

Secondary Outcomes (5)

• Area under the serum concentration time curve (AUC) of INBRX-106

  ~2 years

• Maximum observed serum concentration (Cmax) of INBRX-106

  ~2 years

• Trough observed serum concentration (Ctrough) of INBRX-106

  ~2 years

• Time to Cmax (Tmax) of INBRX-106

  ~2 years

• Immunogenicity of INBRX-106

  ~2 years

Other Outcomes (2)

• Anti-tumor activity of INBRX-106 as single agent and in combination with pembrolizumab with or without chemotherapy

  ~2 years

• Anti-tumor activity of INBRX-106 as single agent and in combination with pembrolizumab with or without chemotherapy

  ~2 years

Study Arms (14)

Part 1 INBRX-106 Escalation (Not Recruiting)

EXPERIMENTAL

INBRX-106 will be escalated in subjects with locally advanced or metastatic solid tumors.

Drug: INBRX-106 - Hexavalent OX40 agonist antibody

Part 3 INBRX-106 Escalation in Combination with pembrolizumab (Not Recruiting)

EXPERIMENTAL

INBRX-106 will be escalated, in combination with pembrolizumab, in subjects with locally advanced or metastatic solid tumors.

Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg

Part 2 (Cohorts C1/C2) INBRX-106 Escalation in Various Solid Tumor Types (Not Recruiting)

EXPERIMENTAL

Subjects with melanoma (any type), head and neck squamous cell carcinoma, renal cell carcinoma, urothelial carcinoma or MSI/TMB-high tumors that are relapsed or refractory to prior checkpoint inhibitor (CPI) therapy will be treated with INBRX-106

Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg

Part 2 (Cohort C3) INBRX-106 Escalation in NSCLC (Not Recruiting)

EXPERIMENTAL

Subjects with non-small cell carcinoma relapsed or refractory to prior checkpoint inhibitor (CPI) therapy will be treated with INBRX-106

Drug: pembrolizumab 200 mg

Part 4 (Cohort F3a) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting)

EXPERIMENTAL

Subjects with non-small cell lung cancer will be treated with alternating dosing of INBRX-106 0.3 mg/kg Q6W and 400 mg pembrolizumab IV Q6W. This is one of the randomized cohorts.

Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 400 mg

Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting)

EXPERIMENTAL

Subjects with non-small cell lung cancer will be given a 0.3 mg/kg priming dose of INBRX-106 in cycle 1, followed by 0.1 mg/kg INBRX-106 and 200 mg pembrolizumab IV every 3 weeks in subsequent cycles. This is one of the randomized cohorts.

Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg; Drug: pembrolizumab 400 mg

Part 4 (Cohort F3c) Pembrolizumab Expansion Arm (Not Recruiting)

ACTIVE COMPARATOR

Subjects with non-small cell lung cancer will be treated with 200 mg pembrolizumab IV every 3 weeks. This is one of the randomized cohorts.

Drug: INBRX-106 - Hexavalent OX40 agonist antibody

Part 4 (Cohort F3d) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (concurrent)

EXPERIMENTAL

Subjects with non-small cell lung cancer will be treated concurrently every 6 weeks with INBRX-106 0.1 mg/kg and 200 mg pembrolizumab IV every 3 weeks. This is one of the randomized cohorts.

Drug: INBRX-106 - Hexavalent OX40 agonist antibody

Part 4 (Cohort F4) INBRX-106 Expansion in Combination with pembrolizumab

EXPERIMENTAL

Subjects with melanoma (any type), head and neck squamous cell carcinoma (non-nasopharyngeal) OR nasopharyngeal carcinoma, MSI-high, TMB-high or MMR-deficient tumors, will be treated with INBRX-106 in combination with 200mg pembrolizumab IV every 3 weeks. Only NPC is currently enrolling.

Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg

Part 4 (Cohort F5)INBRX-106 Expansion with pembrolizumab in MSI/TMB-high/MMRd tumors Not Recuriting

EXPERIMENTAL

Subjects with solid tumors that have confirmed MSI-high, TMB-high or MMR-deficient states who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks

Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg

Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting)

EXPERIMENTAL

Subjects with ocular (uveal) melanoma who are relapsed or refractory to checkpoint inhibitor (CPI) therapy will be treated with INBRX-106 and 200 mg pembrolizumab IV every 3 weeks

Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg; Drug: Carboplatin AUC-5; Drug: Pemetrexed 500 mg/m2

Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC

EXPERIMENTAL

This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and carboplatin AUC-5 IV every 3 weeks

Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg; Drug: Pemetrexed 500 mg/m2; Drug: Cisplatin 75mg/m2

Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC

EXPERIMENTAL

This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 500mg/m2 pemetrexed and 75mg/m2 cisplatin IV every 3 weeks

Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg; Drug: Carboplatin AUC-6; Drug: Paclitaxel 200mg/m2; Drug: Nab paclitaxel 100mg/m2

Part 4(Cohort F7c)INBRX-106 Expansion with pembrolizumab, (Nab)-paclitaxel and carboplatin in NSCLC

EXPERIMENTAL

This Arm is no longer recruiting. Subjects with advanced/metastatic NSCLC, any PD-L1 TPS will be treated with INBRX-106 0.1mg/kg, 200mg pembrolizumab, 200mg/m2 paclitaxel and carboplatin AUC-6 IV every 3 weeks OR INBRX-106, 200mg pembrolizumab, 100mg/m2 nab-paclitaxel (dosed Days 1,8 and 15 every cycle) and carboplatin AUC-6 IV every 3 weeks. Treating physician to determine if paclitaxel or nab-paclitaxel will be given

Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg

Interventions

pembrolizumab 200 mg DRUG

pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.

Also known as: KEYTRUDA

Part 2 (Cohort C3) INBRX-106 Escalation in NSCLC (Not Recruiting); Part 2 (Cohorts C1/C2) INBRX-106 Escalation in Various Solid Tumor Types (Not Recruiting); Part 3 INBRX-106 Escalation in Combination with pembrolizumab (Not Recruiting); Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting); Part 4 (Cohort F4) INBRX-106 Expansion in Combination with pembrolizumab; Part 4 (Cohort F5)INBRX-106 Expansion with pembrolizumab in MSI/TMB-high/MMRd tumors Not Recuriting; Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting); Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC; Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC; Part 4(Cohort F7c)INBRX-106 Expansion with pembrolizumab, (Nab)-paclitaxel and carboplatin in NSCLC

pembrolizumab 400 mg DRUG

pembrolizumab 400 mg by IV infusion given on Day 1 of alternating 21-day cycles (every 6 weeks)

Also known as: KEYTRUDA

Part 4 (Cohort F3a) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting); Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting)

INBRX-106 - Hexavalent OX40 agonist antibody DRUG

The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).

Part 1 INBRX-106 Escalation (Not Recruiting); Part 2 (Cohorts C1/C2) INBRX-106 Escalation in Various Solid Tumor Types (Not Recruiting); Part 3 INBRX-106 Escalation in Combination with pembrolizumab (Not Recruiting); Part 4 (Cohort F3a) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting); Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting); Part 4 (Cohort F3c) Pembrolizumab Expansion Arm (Not Recruiting); Part 4 (Cohort F3d) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (concurrent); Part 4 (Cohort F4) INBRX-106 Expansion in Combination with pembrolizumab; Part 4 (Cohort F5)INBRX-106 Expansion with pembrolizumab in MSI/TMB-high/MMRd tumors Not Recuriting; Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting); Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC; Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC; Part 4(Cohort F7c)INBRX-106 Expansion with pembrolizumab, (Nab)-paclitaxel and carboplatin in NSCLC

Carboplatin AUC-5 DRUG

carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4

Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting)

Carboplatin AUC-6 DRUG

carboplatin AUC-6 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4

Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC

Pemetrexed 500 mg/m2 DRUG

pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle for up to 35 cycles

Also known as: Alimta®

Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting); Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC

Cisplatin 75mg/m2 DRUG

cisplatin 75mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4

Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC

Paclitaxel 200mg/m2 DRUG

paclitaxel 200mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4

Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC

Nab paclitaxel 100mg/m2 DRUG

Nab paclitaxel 100mg/m2 by intravenous (IV) infusion, given on Days 1, 8 and 15 of each 21-day cycle of cycles 1-4

Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC

Eligibility Criteria

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

You may qualify if:

• Males or females aged ≥18 years.
• Parts 1 and 3 (escalation cohorts): Subjects with locally advanced or metastatic non resectable solid tumors, whose disease has progressed despite all standard therapies or for whom no further standard or clinically acceptable therapy exists.
• Part 2 (single-agent expansion cohort): Subjects with NSCLC, melanoma, HNSCC, G/GEA, RCC, or TCC, with histologically confirmed, locally advanced or metastatic, non-resectable disease, which has progressed despite all standard therapies including CPI or for whom no standard or clinically acceptable therapy exists.
• Part 4 (expansion cohorts in combination with pembrolizumab, with or without chemotherapy): Subjects with melanoma (all types), HNSCC, G/GEA, RCC, TCC, NSCLC, or MSI-high, TMB-high, MMR-deficient tumors, with histologically confirmed, locally advanced or metastatic, non resectable disease, which is either CPI-naive (melanoma, HNSCC, NPC) or progressed despite all standard therapies including CPI (NSCLC, RCC, TCC, uveal melanoma, MSI-high, TMB-high, or MMR-deficient solid tumors) or for whom no standard or clinically acceptable therapy exists.
• For Cohort F3 (NSCLC), subjects may have progressed on no more than 2 lines of standard therapy that must include at least one PD-1/L1 regimen.
• For Cohort F4 (HNSCC and NPC), subjects may be previously treated with no more than 1 prior chemotherapy regimen in metastatic setting. Prior PD-1/L1 in curative (neo-adjuvant/adjuvant) setting is allowed only if completed \>/= 6 months prior to progression to local recurrence or metastatic disease.
• All subjects with non-squamous NSCLC must have documentation of absence of tumor activating EGFR mutations and absence of ALK gene rearrangements.
• PD-L1 by IHC (22C3): Parts 1 and 3: IHC optional. Part 2: IHC result mandatory but any score allowed. Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed). Part 4: Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed).
• Adequate hematologic, coagulation, hepatic and renal function and ECOG score as defined per protocol.

You may not qualify if:

• Prior exposure to OX40 agonists.
• Receipt of any investigational product or any approved anticancer drug(s) or biological product(s) within 4 weeks prior to the first dose of study drug with certain exceptions.
• Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin's lymphoma and multiple myeloma)
• Prior or concurrent malignancies. Exception: Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessments of INBRX-106.
• Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Exception: Subjects who are previously treated and are radiologically and clinically stable without the requirement for steroid treatment for at least 14 days prior to first dose of study treatment may be allowed study entry if certain criteria apply.
• Grade ≥ 3 immune-related adverse events (irAEs) or irAE that lead to discontinuation of prior immunotherapy. Some exceptions as defined per protocol apply.
• Active autoimmune disease or documented history of autoimmune disease that required systemic steroids or other immunosuppressive medications. Certain exceptions as defined in protocol apply.
• Diagnosis of immunodeficiency or treatment with systemic immunosuppressive medications within 7 days prior to the first dose of study drug. Certain exceptions as defined in protocol apply.
• History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection. Exceptions as defined in protocol apply.
• Active interstitial lung disease (ILD) or pneumonitis or a history of ILD or pneumonitis requiring treatment with steroids or other immunosuppressive medications.
• Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease \< 3 months; left ventricular ejection fraction (LVEF) \< 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension; or oxygen saturation \<92% on room air.
• Active, hemodynamically significant pulmonary embolism within 3 months prior to enrollment on this trial.
• Major surgery within 4 weeks prior to enrollment on this trial.
• Anti-infectious drug treatments (i.e., antibiotics) within 4 weeks prior to the first dose of study drug.
• Prior organ allograft transplantations or allogeneic peripheral blood stem cell (PBSC) or bone marrow (BM) transplantation.

Sponsors & Collaborators

• Inhibrx Biosciences, Inc: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (42)

City of Hope

Duarte, California, 91010, United States

Location

Los Angeles Cancer Network

Glendale, California, 91204, United States

Location

California Research Institute

Los Angeles, California, 90027, United States

Location

Valkyrie Clinical Trials

Los Angeles, California, 90069, United States

Location

Valkyrie Clinical Trials

Murrieta, California, 92562, United States

Location

Providence Medical Foundation

Santa Rosa, California, 95403, United States

Location

Clermont Oncology Center

Clermont, Florida, 34711, United States

Location

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763, United States

Location

Winship Cancer Institute - Emory University

Atlanta, Georgia, 30322, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Henry Ford Cancer Institute

Detroit, Michigan, 48202, United States

Location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

HealthPartners Cancer Research Center

Saint Louis Park, Minnesota, 55426, United States

Location

HealthPartners Cancer Research Center (Regions Hospital)

Saint Paul, Minnesota, 55101, United States

Location

Intermountain Health Cancer Centers of Montana

Billings, Montana, 59102, United States

Location

Nebraska Cancer Specialists

Omaha, Nebraska, 68130, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Vanderbilt University School of Medicine

Nashville, Tennessee, 37204, United States

Location

Sarah Cannon Research Institute at Mary Crowley

Dallas, Texas, 75230, United States

Location

Renovatio Clinical - El Paso

El Paso, Texas, 79915, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

Renovatio Clinical

The Woodlands, Texas, 77380, United States

Location

The University of Texas Health Science Center at Tyler

Tyler, Texas, 75701, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Curie Oncology

Singapore, Singapore

Location

Icon Cancer Centre Farrer Park

Singapore, Singapore

Location

Icon Cancer Centre Mount Alvernia

Singapore, Singapore

Location

The Catholic University of Korea, St. Vincent's Hospital

Gyeonggi-do, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital,

Seoul, South Korea

Location

Changhua Christian Hospital (CCH)

Changhua, Taiwan

Location

E-Da Cancer Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

Kaohsiung City, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Holay N, Yadav R, Ahn SJ, Kasiewicz MJ, Polovina A, Rolig AS, Staebler T, Becklund B, Simons ND, Koguchi Y, Eckelman BP, de Durana YD, Redmond WL. INBRX-106: a hexavalent OX40 agonist that drives superior antitumor responses via optimized receptor clustering. J Immunother Cancer. 2025 May 21;13(5):e011524. doi: 10.1136/jitc-2025-011524.

  PMID: 40404202 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Melanoma; Stomach Neoplasms; Carcinoma, Renal Cell; Carcinoma, Transitional Cell; Lung Neoplasms; Squamous Cell Carcinoma of Head and Neck; Oropharyngeal Neoplasms; Hypopharyngeal Neoplasms; Mouth Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site; Carcinoma; Carcinoma, Squamous Cell

Interventions

pembrolizumab; Pemetrexed; Cisplatin; Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Adenocarcinoma; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases

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; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Study Officials

• Clinical Lead

  Inhibrx Biosciences, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Part 4 NSCLC cohort is randomized 1;1:1, open-label
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2019
• First Posted: December 13, 2019
• Study Start: December 10, 2019
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): May 12, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4); US (30); TW (5); SG (3)