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Clinical Trials in the USA / NCT04198766
Recruiting Phase 1/2

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 · tracked via the Priya Life Science USA tracker
Sponsor
Inhibrx Biosciences, Inc
Phase
Phase 1/2
Started
2019-12-10
Last updated
2026-07-29

Condition(s) studied

Solid TumorNon-Small Cell Lung CancerHead and Neck CancerMelanomaGastric CancerRenal Cell CarcinomaUrothelial CarcinomaResectable Non-Small-Cell Lung Cancer

Investigational drug(s) / intervention(s)

INBRX-106 - Hexavalent OX40 agonist antibodypembrolizumab 200 mgpembrolizumab 400 mgCarboplatin AUC-5Carboplatin AUC-6Pemetrexed 500 mg/m2Cisplatin 75mg/m2Paclitaxel 200mg/m2Nab paclitaxel 100mg/m2Gemcitabine (1000 mg/m2)

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).

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

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

Carboplatin AUC-5: carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4. Cohort F8, carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycle 2-4.

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

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. In Cohort F8, pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle of cycles 1-4.

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

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

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

Gemcitabine (1000 mg/m2): Gemcitabine 1000 mg/m2 given by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle of cycles 1-4

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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. * For Cohort F8, subjects must have previously untreated, histologically confirmed Stage II, IIIA or IIIB (T3-4N2) NSCLC. Lymph node disease requires histologic confirmation, while T3 disease requires only radiographic documentation. Subjects need to be able to undergo planned surgery. * 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). For Cohort F8, any TPS (including 0%) is acceptable. * Adequate hematologic, coagulation, hepatic and renal function and ECOG score as defined per protocol. Select Exclusion Criteria: * Prior exposure to OX40 agonists. Exposure to anti-PD-1 and/or anti PD-L2 CPIs or an agent targeting other co-stimulatory T-cell receptor pathways. * 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. * 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, viral myocarditis, cerebrovascular accident, or other acute uncontrolled heart disease \< 3 months prior to enrollment on this trial; 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 12 weeks 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.

Primary outcome measure(s)

Trial sites (42)

FacilityCityRegionStatus
City of Hope Duarte California Recruiting
Los Angeles Cancer Network Glendale California Recruiting
California Research Institute Los Angeles California Recruiting
Valkyrie Clinical Trials Los Angeles California Recruiting
Valkyrie Clinical Trials Murrieta California Recruiting
Providence Medical Foundation Santa Rosa California Recruiting
Clermont Oncology Center Clermont Florida Recruiting
Mid Florida Hematology and Oncology Center Orange City Florida Recruiting
Winship Cancer Institute - Emory University Atlanta Georgia Recruiting
The University of Chicago Medical Center Chicago Illinois Active Not Recruiting
University of Iowa Iowa City Iowa Active Not Recruiting
Norton Cancer Institute Louisville Kentucky Recruiting
Barbara Ann Karmanos Cancer Institute Detroit Michigan Completed
Henry Ford Cancer Institute Detroit Michigan Recruiting
START Midwest Grand Rapids Michigan Active Not Recruiting
HealthPartners Cancer Research Center Saint Louis Park Minnesota Active Not Recruiting
HealthPartners Cancer Research Center (Regions Hospital) Saint Paul Minnesota Completed
Intermountain Health Cancer Centers of Montana Billings Montana Completed
Nebraska Cancer Specialists Omaha Nebraska Recruiting
Montefiore Medical Center The Bronx New York Active Not Recruiting
Cleveland Clinic Cleveland Ohio Active Not Recruiting
Providence Portland Medical Center Portland Oregon Active Not Recruiting
Vanderbilt University School of Medicine Nashville Tennessee Active Not Recruiting
Sarah Cannon Research Institute at Mary Crowley Dallas Texas Completed
Renovatio Clinical - El Paso El Paso Texas Completed
NEXT Oncology San Antonio Texas Completed
Renovatio Clinical The Woodlands Texas Completed
The University of Texas Health Science Center at Tyler Tyler Texas Recruiting
Virginia Cancer Specialists Fairfax Virginia Completed
Froedtert Hospital and the Medical College of Wisconsin Milwaukee Wisconsin Active Not Recruiting
Curie Oncology Singapore Singapore Completed
Icon Cancer Centre Farrer Park Singapore Singapore Completed
Icon Cancer Centre Mount Alvernia Singapore Singapore Completed
The Catholic University of Korea, St. Vincent's Hospital Gyeonggi-do South Korea Active Not Recruiting
Asan Medical Center Seoul South Korea Active Not Recruiting
Severance Hospital, Yonsei University Health System Seoul South Korea Active Not Recruiting
The Catholic University of Korea Seoul St. Mary's Hospital, Seoul South Korea Active Not Recruiting
Changhua Christian Hospital (CCH) Changhua Taiwan Active Not Recruiting
E-Da Cancer Hospital Kaohsiung City Taiwan Active Not Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH) Kaohsiung City Taiwan Active Not Recruiting

+ 2 more sites — see the full list on the official registry below.

More Inhibrx Biosciences, Inc trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04198766 on ClinicalTrials.gov ↗ ← All trials in the USA