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Study of INBRX-106 with or without Pembrolizumab for Advanced Solid Tumors

This study is testing INBRX-106, alone or combined with pembrolizumab (Keytruda®), for people with locally advanced or metastatic solid tumors, including non-small cell lung cancer, head and neck cancer, melanoma, and gastric cancer. You might be eligible if your disease has progressed despite standard treatments or if no other standard options are available. The main goals are to understand the safety of INBRX-106 and to find the best dose to use in future studies. Researchers will be looking at how often side effects occur and how severe they are over about two years. This study aims to find the safest and most effective dose of these treatments.

Study design
This is a Phase 1/2, open-label (meaning you and your doctors will know which treatment you are receiving), non-randomized study with 340 planned participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The frequency and severity of adverse events will be measured for approximately two years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04198766

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Inhibrx Biosciences, Inc
~340 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:INBRX-106 - Hexavalent OX40 agonist antibodypembrolizumab 200 mgpembrolizumab 400 mgCarboplatin AUC-5Carboplatin AUC-6Pemetrexed 500 mg/m2

At a glance

Recruiting sites
13 of 42 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab
Measured over ~2 years
+5 more outcomes measured

Conditions

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

Explore related trials

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NCT04198766

Where you'd take part

This study runs at 42 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • California Research Institute

    Los Angeles, Californiastudy coordinator listed

    Recruiting

  • City of Hope

    Duarte, Californiastudy coordinator listed

    Recruiting

  • Clermont Oncology Center

    Clermont, Floridastudy coordinator listed

    Recruiting

  • Henry Ford Cancer Institute

    Detroit, Michiganstudy coordinator listed

    Recruiting

  • Los Angeles Cancer Network

    Glendale, Californiastudy coordinator listed

    Recruiting

  • Mid Florida Hematology and Oncology Center

    Orange City, Floridastudy coordinator listed

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraskastudy coordinator listed

    Recruiting

  • Norton Cancer Institute

    Louisville, Kentuckystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Clinical Lead · STUDY_DIRECTOR · Inhibrx Biosciences, Inc

Who to contact

Study Director - Inhibrx Biosciences, Inc
[email protected]
858-500-7833
Email the study team

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab~2 years

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

  • Severity of adverse events of INBRX-106 as single agent and in combination with pembrolizumab~2 years

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

  • MTD and/or RP2D of INBRX-106 as single agent and in combination with pembrolizumab~2 years

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

  • Antitumor activity of INBRX-106 in combination with pembrolizumab in expansion cohorts~2 years

    The evaluation of efficacy will be based on the subject's measurable disease using RECIST v1.1

  • Frequency and severity of adverse events of INBRX-106 in combination with pembrolizumab and chemotherapy in adults with locally advanced or metastatic NSCLC or resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC~2 years

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

  • To assess the antitumor activity of INBRX-106 in combination with pembrolizumab and platinum doublet chemotherapy as neoadjuvant/adjuvant therapy in adult subjects with NSCLC. (Cohort F8)~2 years

    Major pathological response (mPR) and pathological complete response (cPR) criteria.