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

NCT ID: NCT04198766

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

296 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2027-05-12

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Part 4 NSCLC cohort is randomized 1;1:1, open-label

Study Groups

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Part 1 INBRX-106 Escalation (Not Recruiting)

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

Group Type EXPERIMENTAL

INBRX-106 - Hexavalent OX40 agonist antibody

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

INBRX-106 - Hexavalent OX40 agonist antibody

Intervention Type DRUG

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

pembrolizumab 200 mg

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

INBRX-106 - Hexavalent OX40 agonist antibody

Intervention Type DRUG

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

pembrolizumab 200 mg

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

pembrolizumab 200 mg

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

INBRX-106 - Hexavalent OX40 agonist antibody

Intervention Type DRUG

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

pembrolizumab 400 mg

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

INBRX-106 - Hexavalent OX40 agonist antibody

Intervention Type DRUG

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

pembrolizumab 200 mg

Intervention Type DRUG

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

pembrolizumab 400 mg

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

INBRX-106 - Hexavalent OX40 agonist antibody

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

INBRX-106 - Hexavalent OX40 agonist antibody

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

INBRX-106 - Hexavalent OX40 agonist antibody

Intervention Type DRUG

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

pembrolizumab 200 mg

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

INBRX-106 - Hexavalent OX40 agonist antibody

Intervention Type DRUG

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

pembrolizumab 200 mg

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

INBRX-106 - Hexavalent OX40 agonist antibody

Intervention Type DRUG

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

pembrolizumab 200 mg

Intervention Type DRUG

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

Carboplatin AUC-5

Intervention Type DRUG

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

Pemetrexed 500 mg/m2

Intervention Type DRUG

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

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

Group Type EXPERIMENTAL

INBRX-106 - Hexavalent OX40 agonist antibody

Intervention Type DRUG

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

pembrolizumab 200 mg

Intervention Type DRUG

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

Pemetrexed 500 mg/m2

Intervention Type DRUG

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

Cisplatin 75mg/m2

Intervention Type DRUG

cisplatin 75mg/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

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

Group Type EXPERIMENTAL

INBRX-106 - Hexavalent OX40 agonist antibody

Intervention Type DRUG

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

pembrolizumab 200 mg

Intervention Type DRUG

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

Carboplatin AUC-6

Intervention Type DRUG

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

Paclitaxel 200mg/m2

Intervention Type DRUG

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

Nab paclitaxel 100mg/m2

Intervention Type 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 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

Group Type EXPERIMENTAL

INBRX-106 - Hexavalent OX40 agonist antibody

Intervention Type DRUG

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

pembrolizumab 200 mg

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

pembrolizumab 200 mg

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

Intervention Type DRUG

pembrolizumab 400 mg

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

Intervention Type DRUG

Carboplatin AUC-5

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

Intervention Type DRUG

Carboplatin AUC-6

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

Intervention Type 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

Intervention Type DRUG

Cisplatin 75mg/m2

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

Intervention Type DRUG

Paclitaxel 200mg/m2

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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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KEYTRUDA KEYTRUDA Alimta®

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Inhibrx Biosciences, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Lead

Role: STUDY_DIRECTOR

Inhibrx Biosciences, Inc

Locations

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City of Hope

Duarte, California, United States

Site Status

Los Angeles Cancer Network

Glendale, California, United States

Site Status

California Research Institute

Los Angeles, California, United States

Site Status

Valkyrie Clinical Trials

Los Angeles, California, United States

Site Status

Valkyrie Clinical Trials

Murrieta, California, United States

Site Status

Providence Medical Foundation

Santa Rosa, California, United States

Site Status

Clermont Oncology Center

Clermont, Florida, United States

Site Status

Mid Florida Hematology and Oncology Center

Orange City, Florida, United States

Site Status

Winship Cancer Institute - Emory University

Atlanta, Georgia, United States

Site Status

The University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

Norton Cancer Institute

Louisville, Kentucky, United States

Site Status

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Henry Ford Cancer Institute

Detroit, Michigan, United States

Site Status

START Midwest

Grand Rapids, Michigan, United States

Site Status

HealthPartners Cancer Research Center

Saint Louis Park, Minnesota, United States

Site Status

HealthPartners Cancer Research Center (Regions Hospital)

Saint Paul, Minnesota, United States

Site Status

Intermountain Health Cancer Centers of Montana

Billings, Montana, United States

Site Status

Nebraska Cancer Specialists

Omaha, Nebraska, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

Vanderbilt University School of Medicine

Nashville, Tennessee, United States

Site Status

Sarah Cannon Research Institute at Mary Crowley

Dallas, Texas, United States

Site Status

Renovatio Clinical - El Paso

El Paso, Texas, United States

Site Status

NEXT Oncology

San Antonio, Texas, United States

Site Status

Renovatio Clinical

The Woodlands, Texas, United States

Site Status

The University of Texas Health Science Center at Tyler

Tyler, Texas, United States

Site Status

Virginia Cancer Specialists

Fairfax, Virginia, United States

Site Status

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Curie Oncology

Singapore, , Singapore

Site Status

Icon Cancer Centre Farrer Park

Singapore, , Singapore

Site Status

Icon Cancer Centre Mount Alvernia

Singapore, , Singapore

Site Status

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

Gyeonggi-do, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

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

Seoul, , South Korea

Site Status

Changhua Christian Hospital (CCH)

Changhua, , Taiwan

Site Status

E-Da Cancer Hospital

Kaohsiung City, , Taiwan

Site Status

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

Kaohsiung City, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan, , Taiwan

Site Status

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status

Countries

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United States Singapore South Korea Taiwan

References

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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.

Reference Type DERIVED
PMID: 40404202 (View on PubMed)

Other Identifiers

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KEYNOTE A99 and MK-3475-A99

Identifier Type: OTHER

Identifier Source: secondary_id

Ph 1 Ph 2 INBRX-106

Identifier Type: -

Identifier Source: org_study_id