RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing INBRX-106 - Hexavalent OX40 agonist antibody for Solid Tumor

This is a Phase 1/2, open-label, non-randomly assigned, 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.

Official registry: https://clinicaltrials.gov/study/NCT04198766 · Inhibrx Biosciences, Inc · enrollment listed as 340

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab 200 mg, or pembrolizumab 400 mg. The registry lists allocation as randomized. This is a Phase 1/2, open-label, non-randomly assigned, 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®).

They plan to enroll about 340 people at 60 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: INBRX-106 - Hexavalent OX40 agonist antibody, pembrolizumab 200 mg, pembrolizumab 400 mg, Carboplatin AUC-5, Carboplatin AUC-6, Pemetrexed 500 mg/m2, Cisplatin 75mg/m2, Paclitaxel 200mg/m2, Nab paclitaxel 100mg/m2, Gemcitabine (1000 mg/m2)

Primary outcome (registry wording): Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab

Who it is for (from inclusion criteria)

Ages 18 Years to any
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
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
All subjects with non-squamous NSCLC must have documentation of absence of tumor activating EGFR mutations and absence of ALK gene rearrangements
Adequate hematologic, coagulation, hepatic and renal function and ECOG score as defined per protocol

Who the registry excludes

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 how well it works assessments of INBRX-106
Grade ≥ 3 immune-related side effects (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

Public study contact (from the registry)

Study Director - Inhibrx Biosciences, Inc

858-500-7833

clinicaltrials@inhibrx.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

60 listed

City of Hope — Duarte, California (active_not_recruiting)
Oncura Health — Glendale, California (recruiting)
UC San Diego Health - Moores Cancer Center — La Jolla, California (not_yet_recruiting)
California Research Institute — Los Angeles, California (recruiting)
University of Southern California Norris Comprehensive Cancer Center — Los Angeles, California (not_yet_recruiting)
Valkyrie Clinical Trials — Los Angeles, California (recruiting)
Valkyrie Clinical Trials — Murrieta, California (recruiting)
Providence Medical Foundation — Santa Rosa, California (recruiting)
Valkyrie Clinical Trials - Colorado — Lakewood, Colorado (not_yet_recruiting)
Clermont Oncology Center — Clermont, Florida (recruiting)
Mid Florida Hematology and Oncology Center — Orange City, Florida (recruiting)
Winship Cancer Institute - Emory University — Atlanta, Georgia (active_not_recruiting)

+ 21 sites outside the US on the same record

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FAQ about this NCT record

Is NCT04198766 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT04198766?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT04198766?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary