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

An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Multicohort, Phase 1/2 Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab in Subjects With Locally Advanced or Metastatic Solid Tumors

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Melanoma; Renal Cell Carcinoma; Head and Neck Cancer; Gastric Cancer; Non-Small Cell Lung Cancer; Solid Tumor; Urothelial Carcinoma
• Intervention / Treatment: Drug: INBRX-106 - Hexavalent OX40 agonist antibody; Drug: pembrolizumab 200 mg; Drug: pembrolizumab 400 mg; Drug: Carboplatin AUC-5; Drug: Pemetrexed 500 mg/m2; Drug: Cisplatin 75mg/m2; Drug: Carboplatin AUC-6; Drug: Paclitaxel 200mg/m2; Drug: Nab paclitaxel 100mg/m2

• Study Type: Interventional
• Enrollment (Actual): 296
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • Curie Oncology
  • Singapore, Singapore
    • Icon Cancer Centre Farrer Park
  • Singapore, Singapore
    • Icon Cancer Centre Mount Alvernia
• South Korea
  • Gyeonggi-do, South Korea
    • The Catholic university of Korea, St. Vincent's Hospital
  • Seoul, South Korea
    • Asan Medical Center
  • Seoul, South Korea
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea
    • The Catholic University of Korea Seoul St. Mary's Hospital,
• Taiwan
  • Changhua, Taiwan
    • Changhua Christian Hospital (CCH)
  • Kaohsiung City, Taiwan
    • E-Da Cancer Hospital
  • Kaohsiung City, Taiwan
    • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
  • Tainan, Taiwan
    • National Cheng Kung University Hospital
  • Taipei, Taiwan
    • Taipei Veterans General Hospital
• United States
  • California
    • Duarte, California, United States, 91010
      • City of Hope
    • Glendale, California, United States, 91204
      • Los Angeles Cancer Network
    • Los Angeles, California, United States, 90027
      • California Research Institute
    • Los Angeles, California, United States, 90069
      • Valkyrie Clinical Trials
    • Murrieta, California, United States, 92562
      • Valkyrie Clinical Trials
    • Santa Rosa, California, United States, 95403
      • Providence Medical Foundation
  • Florida
    • Clermont, Florida, United States, 34711
      • Clermont Oncology Center
    • Orange City, Florida, United States, 32763
      • Mid Florida Hematology and Oncology Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute - Emory University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medical Center
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Norton Cancer Institute
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Institute
    • Detroit, Michigan, United States, 48202
      • Henry Ford Cancer Institute
    • Grand Rapids, Michigan, United States, 49546
      • Start Midwest
  • Minnesota
    • Saint Louis Park, Minnesota, United States, 55426
      • HealthPartners Cancer Research Center
    • Saint Paul, Minnesota, United States, 55101
      • HealthPartners Cancer Research Center (Regions Hospital)
  • Montana
    • Billings, Montana, United States, 59102
      • Intermountain Health Cancer Centers of Montana
  • Nebraska
    • Omaha, Nebraska, United States, 68130
      • Nebraska Cancer Specialists
  • New York
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37204
      • Vanderbilt University School of Medicine
  • Texas
    • Dallas, Texas, United States, 75230
      • Sarah Cannon Research Institute at Mary Crowley
    • El Paso, Texas, United States, 79915
      • Renovatio Clinical - El Paso
    • San Antonio, Texas, United States, 78229
      • NEXT Oncology
    • The Woodlands, Texas, United States, 77380
      • Renovatio Clinical
    • Tyler, Texas, United States, 75701
      • The University of Texas Health Science Center at Tyler
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital and the Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Select Inclusion Criteria:

• 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.

Select Exclusion Criteria:

• 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.
• Additional in- and exclusion criteria per protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

14

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 INBRX-106 Escalation (Not Recruiting); INBRX-106 will be escalated in subjects with locally advanced or metastatic solid tumors.	Drug: INBRX-106 - Hexavalent OX40 agonist antibody; The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).
Experimental: Part 3 INBRX-106 Escalation in Combination with pembrolizumab (Not Recruiting); 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; The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).; Drug: pembrolizumab 200 mg; pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.; Other Names: KEYTRUDA
Experimental: Part 2 (Cohorts C1/C2) INBRX-106 Escalation in Various Solid Tumor Types (Not Recruiting); 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; The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).; Drug: pembrolizumab 200 mg; pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.; Other Names: KEYTRUDA
Active Comparator: Part 4 (Cohort F3c) Pembrolizumab Expansion Arm (Not Recruiting); 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; The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).
Experimental: Part 4 (Cohort F3d) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (concurrent); 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; The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).
Experimental: Part 4 (Cohort F5)INBRX-106 Expansion with pembrolizumab in MSI/TMB-high/MMRd tumors Not Recuriting; 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; The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).; Drug: pembrolizumab 200 mg; pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.; Other Names: KEYTRUDA
Experimental: Part 2 (Cohort C3) INBRX-106 Escalation in NSCLC (Not Recruiting); 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; pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.; Other Names: KEYTRUDA
Experimental: Part 4 (Cohort F3a) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting); 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; The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).; Drug: pembrolizumab 400 mg; pembrolizumab 400 mg by IV infusion given on Day 1 of alternating 21-day cycles (every 6 weeks); Other Names: KEYTRUDA
Experimental: Part 4 (Cohort F3b) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not Recruiting); 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; The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).; Drug: pembrolizumab 200 mg; pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.; Other Names: KEYTRUDA; Drug: pembrolizumab 400 mg; pembrolizumab 400 mg by IV infusion given on Day 1 of alternating 21-day cycles (every 6 weeks); Other Names: KEYTRUDA
Experimental: Part 4 (Cohort F4) INBRX-106 Expansion in Combination with pembrolizumab; 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; The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).; Drug: pembrolizumab 200 mg; pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.; Other Names: KEYTRUDA
Experimental: Part 4 (Cohort F6) INBRX-106 Expansion with pembrolizumab in Uveal Melanoma (Not Recruiting); 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; The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).; Drug: pembrolizumab 200 mg; pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.; Other Names: KEYTRUDA; Drug: Carboplatin AUC-5; carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4; Drug: Pemetrexed 500 mg/m2; pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle for up to 35 cycles; Other Names: Alimta®
Experimental: Part 4 (Cohort F7a) INBRX-106 Expansion with pembrolizumab, pemetrexed and carboplatin in NSCLC; 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; The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).; Drug: pembrolizumab 200 mg; pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.; Other Names: KEYTRUDA; Drug: Pemetrexed 500 mg/m2; pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle for up to 35 cycles; Other Names: Alimta®; Drug: Cisplatin 75mg/m2; cisplatin 75mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4
Experimental: Part 4 (Cohort F7b) INBRX-106 Expansion with pembrolizumab, pemetrexed and cisplatin in NSCLC; 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; The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).; Drug: pembrolizumab 200 mg; pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.; Other Names: KEYTRUDA; Drug: Carboplatin AUC-6; carboplatin AUC-6 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4; Drug: Paclitaxel 200mg/m2; paclitaxel 200mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4; Drug: Nab paclitaxel 100mg/m2; Nab paclitaxel 100mg/m2 by intravenous (IV) infusion, given on Days 1, 8 and 15 of each 21-day cycle of cycles 1-4
Experimental: Part 4(Cohort F7c)INBRX-106 Expansion with pembrolizumab, (Nab)-paclitaxel and carboplatin in NSCLC; 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; The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).; Drug: pembrolizumab 200 mg; pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.; Other Names: KEYTRUDA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the serum concentration time curve (AUC) of INBRX-106	Area under the serum concentration time curve (AUC) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.	~2 years
Maximum observed serum concentration (Cmax) of INBRX-106	Maximum observed serum concentration (Cmax) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.	~2 years
Trough observed serum concentration (Ctrough) of INBRX-106	Trough observed serum concentration (Ctrough) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.	~2 years
Time to Cmax (Tmax) of INBRX-106	Time to Cmax (Tmax) of INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.	~2 years
Immunogenicity of INBRX-106	Frequency of anti-drug antibodies (ADA) against INBRX-106 as a single agent and in combination with pembrolizumab with or without chemotherapy will be determined.	~2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anti-tumor activity of INBRX-106 as single agent and in combination with pembrolizumab with or without chemotherapy	Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1).	~2 years
Anti-tumor activity of INBRX-106 as single agent and in combination with pembrolizumab with or without chemotherapy	Tumor response will be determined by immune Response Evaluation Criteria in Solid Tumors (iRECIST).	~2 years

Collaborators and Investigators

• Sponsor: Inhibrx Biosciences, Inc
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Study Director: Clinical Lead, Inhibrx Biosciences, Inc

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): May 12, 2027

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Lung Cancer; NSCLC; Non-Small Cell Lung Cancer; Carcinoma; Neoplasms; Immunotherapy; Pembrolizumab; Chemotherapy; Keytruda; HNSCC; Antineoplastic Agents; Solid Tumors; Oral cancer; Oropharyngeal cancer; INBRX-106; Antineoplastic Agents, Immunological; Head and Neck Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms by Site; Squamous Cell Carcinoma of Head and Neck; Molecular Mechanisms of Pharmacological Action; PD-L1 positive; Neoplasms, Squamous Cell; Carcinoma, Squamous Cell; Hypopharyngeal cancer; Phase 1 and Phase 2; Phase 1 and Phase 2 Clinical Trial; OX40 receptor agonist
• Additional Relevant MeSH Terms: Urogenital Diseases; Mouth Diseases; Stomatognathic Diseases; Urogenital Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Lung Diseases; Adenocarcinoma; Respiratory Tract Neoplasms; Thoracic Neoplasms; Skin Diseases; Urologic Neoplasms; Otorhinolaryngologic Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Kidney Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuroendocrine Tumors; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Squamous Cell Carcinoma of Head and Neck; Neoplasms; Stomach Neoplasms; Carcinoma; Lung Neoplasms; Carcinoma, Squamous Cell; Carcinoma, Renal Cell; Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Melanoma; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Mouth Neoplasms; Carcinoma, Transitional Cell; Oropharyngeal Neoplasms; Neoplasms by Site; Hypopharyngeal Neoplasms; Amino Acids, Peptides, and Proteins; Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Hydrocarbons; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Diterpenes; Health Care Economics and Organizations; Platinum Compounds; Economics; Pemetrexed; Paclitaxel; Cisplatin; pembrolizumab; Taxes
• Other Study ID Numbers: Ph 1 Ph 2 INBRX-106; KEYNOTE A99 and MK-3475-A99 (Other Identifier: Merck Sharp & Dohme LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No