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

July 28, 2026 updated by: Inhibrx Biosciences, Inc

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

340

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore
        • Completed
        • Curie Oncology
      • Singapore, Singapore
        • Completed
        • Icon Cancer Centre Farrer Park
      • Singapore, Singapore
        • Completed
        • Icon Cancer Centre Mount Alvernia
  • South Korea
      • Gyeonggi-do, South Korea
        • Active, not recruiting
        • The Catholic University of Korea, St. Vincent's Hospital
      • Seoul, 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,
  • Taiwan
      • Changhua, Taiwan
        • Active, not recruiting
        • Changhua Christian Hospital (CCH)
      • Kaohsiung City, Taiwan
        • Active, not recruiting
        • E-Da Cancer Hospital
      • Kaohsiung City, Taiwan
        • Active, not recruiting
        • Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)
      • Tainan, Taiwan
        • Active, not recruiting
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • Completed
        • Taipei Veterans General Hospital
  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Principal Investigator:
          • Aditya Shreenivas, MD
        • Contact:
      • Glendale, California, United States, 91204
        • Recruiting
        • Los Angeles Cancer Network
        • Contact:
        • Principal Investigator:
          • Sungwon Kyung, MD
      • Los Angeles, California, United States, 90027
        • Recruiting
        • California Research Institute
        • Principal Investigator:
          • Ghassan Al-Jazayrly, MD
        • Contact:
      • Los Angeles, California, United States, 90069
      • Murrieta, California, United States, 92562
        • Recruiting
        • Valkyrie Clinical Trials
        • Principal Investigator:
          • David Berz, MD
        • Contact:
      • Santa Rosa, California, United States, 95403
        • Recruiting
        • Providence Medical Foundation
        • Principal Investigator:
          • Ian Anderson, MD
        • Contact:
    • Florida
      • Clermont, Florida, United States, 34711
        • Recruiting
        • Clermont Oncology Center
        • Principal Investigator:
          • Gopal Kunta, MD
        • Contact:
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Mid Florida Hematology and Oncology Center
        • Principal Investigator:
          • Santosh Nair, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute - Emory University
        • Principal Investigator:
          • Conor Steuer, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Active, not recruiting
        • The University of Chicago Medical Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Active, not recruiting
        • University of Iowa
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Cancer Institute
        • Principal Investigator:
          • Amy Weise, MD
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Completed
        • Barbara Ann Karmanos Cancer Institute
      • Grand Rapids, Michigan, United States, 49546
        • Active, not recruiting
        • Start Midwest
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55426
        • Active, not recruiting
        • HealthPartners Cancer Research Center
      • Saint Paul, Minnesota, United States, 55101
        • Completed
        • HealthPartners Cancer Research Center (Regions Hospital)
    • Montana
      • Billings, Montana, United States, 59102
        • Completed
        • Intermountain Health Cancer Centers of Montana
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Nebraska Cancer Specialists
        • Principal Investigator:
          • Ralph Hauke, MD
        • Contact:
    • New York
      • The Bronx, New York, United States, 10467
        • Active, not recruiting
        • Montefiore Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Active, not recruiting
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97213
        • Active, not recruiting
        • Providence Portland Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Active, not recruiting
        • Vanderbilt University School of Medicine
    • Texas
      • Dallas, Texas, United States, 75230
        • Completed
        • Sarah Cannon Research Institute at Mary Crowley
      • El Paso, Texas, United States, 79915
        • Completed
        • Renovatio Clinical - El Paso
      • San Antonio, Texas, United States, 78229
        • Completed
        • NEXT Oncology
      • The Woodlands, Texas, United States, 77380
        • Completed
        • Renovatio Clinical
      • Tyler, Texas, United States, 75701
        • Recruiting
        • The University of Texas Health Science Center at Tyler
        • Contact:
        • Principal Investigator:
          • Erminia Massarelli, MD, PhD, MS
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Completed
        • Virginia Cancer Specialists
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Active, not recruiting
        • Froedtert Hospital and the Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

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 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 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. Cohort F8, carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycle 2-4.
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. In Cohort F8, pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle of cycles 1-4.
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: Cisplatin 75mg/m2
cisplatin 75mg/m2 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. In Cohort F8, pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle of cycles 1-4.
Other Names:
  • Alimta®
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
Experimental: Part 4 (Cohort F3d) INBRX-106 Expansion in Combination with pembrolizumab in NSCLC (Not-Recruiting)
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 F4) INBRX-106 Expansion in Combination with pembrolizumab (Not Recruiting)
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.
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 F8)INBRX-106 with pembrolizumab, cisplatin and gemcitabine or pemetrexed in NSCLC
Subjects with resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC , any PD-L1 TPS will receive neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 (dosed Day 1 only) with gemcitabine 1000 mg/m2 (dosed on Days 1 and 8) for patients with squamous cell NSCLC given every 3 weeks OR neoadjuvant treatment with INBRX-106 0.1 mg/kg, 200 mg pembrolizumab, cisplatin 75 mg/m2 with pemetrexed 500 mg/m2 for patients with non-squamous cell NSCLC given every 3 weeks. Carboplatin AUC5 (dosed on Day 1 only) can be substituted for Cisplatin following Cycle 1 at the Investigator's discretion and per protocol and due to cisplatin-related toxicity. Neoadjuvant treatment will be given for up to 4 cycles followed by surgery (lobectomy, bilobectomy or pneumonectomy). After surgery, all patients will receive adjuvant treatment consisting of INBRX-106 0.1 mg/kg, 200 mg pembrolizumab given every 3 weeks for up to 13 cycles.
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: Cisplatin 75mg/m2
cisplatin 75mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4
Drug: 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.
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. In Cohort F8, pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle of cycles 1-4.
Other Names:
  • Alimta®
Drug: 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

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
Time Frame: ~2 years
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
Time Frame: ~2 years
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
Time Frame: ~2 years
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
Time Frame: ~2 years
The evaluation of efficacy will be based on the subject's measurable disease using RECIST v1.1
~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 or resectable Stage II, IIIA or IIIB (T3-4N2) NSCLC
Time Frame: ~2 years
Adverse events will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
~2 years
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)
Time Frame: ~2 years
Major pathological response (mPR) and pathological complete response (cPR) criteria.
~2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the serum concentration time curve (AUC) of INBRX-106
Time Frame: ~2 years
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
Time Frame: ~2 years
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
Time Frame: ~2 years
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 Frame: ~2 years
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
Time Frame: ~2 years
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
Time Frame: ~2 years
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
Time Frame: ~2 years
Tumor response will be determined by Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
~2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inhibrx Biosciences, Inc

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Clinical Lead, Inhibrx Biosciences, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2019

Primary Completion (Estimated)

July 1, 2033

Study Completion (Estimated)

July 1, 2033

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 (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 28, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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