Recruiting
Phase 1
Phase 2

INBRX-106 & Pembrolizumab

Sponsor:

Inhibrx Biosciences, Inc

Code:

NCT04198766

Conditions

Solid Tumor

Non-Small Cell Lung Cancer

Head and Neck Cancer

Melanoma

Gastric Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INBRX-106 - Hexavalent OX40 agonist antibody

pembrolizumab 200 mg

pembrolizumab 400 mg

Carboplatin AUC-5

Carboplatin AUC-6

Study Details

Brief 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.

Conditions

Solid Tumor

Non-Small Cell Lung Cancer

Head and Neck Cancer

Melanoma

Gastric Cancer

Study ID

NCT04198766

Start date

Dec 10, 2019

Status verified date

Jul, 2026

Completion date

Jul, 2033

Anticipated

Primary completion date

Jul, 2033

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

340 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1 INBRX-106 Escalation (Not Recruiting)

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

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.

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

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

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.

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.

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.

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.

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.

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

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

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

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

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

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.

Interventions

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

Primary outcome measure

  • Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab [ Time Frame: ~2 years ]
  • Severity of adverse events of INBRX-106 as single agent and in combination with pembrolizumab [ Time Frame: ~2 years ]
  • MTD and/or RP2D of INBRX-106 as single agent and in combination with pembrolizumab [ Time Frame: ~2 years ]
  • Antitumor activity of INBRX-106 in combination with pembrolizumab in expansion cohorts [ Time Frame: ~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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Study Director - Inhibrx Biosciences, Inc

858-500-7833clinicaltrials@inhibrx.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

New Patient Services

800-826-4673shhussain@coh.org

Principal Investigator:

Aditya Shreenivas, MD

Los Angeles Cancer Network

Recruiting

Glendale, California, United States, 91204

Contacts

Elizabeth Brown

Elizabeth.Brown@lahomg.com

Principal Investigator:

Sungwon Kyung, MD

California Research Institute

Recruiting

Los Angeles, California, United States, 90027

Contacts

Swati Shrestha

sw@caresinst.com

Principal Investigator:

Ghassan Al-Jazayrly, MD

Valkyrie Clinical Trials

Recruiting

Los Angeles, California, United States, 90069

Contacts

Myo Zaw

myo.zaw@valkyrieclinicaltrials.com

Principal Investigator:

David Berz, MD

Valkyrie Clinical Trials

Recruiting

Murrieta, California, United States, 92562

Contacts

Isabella Gudino

Isabella.gudino@vctcare.com

Principal Investigator:

David Berz, MD

Providence Medical Foundation

Recruiting

Santa Rosa, California, United States, 95403

Contacts

Clinical Research Coordinator

707-521-3810jackson.barnard@providence.org

Principal Investigator:

Ian Anderson, MD

Clermont Oncology Center

Recruiting

Clermont, Florida, United States, 34711

Contacts

Kiran Penta

kiran@aorcorp.com

Principal Investigator:

Gopal Kunta, MD

Mid Florida Hematology and Oncology Center

Recruiting

Orange City, Florida, United States, 32763

Contacts

Kiran Penta

kiran@aorcorp.com

Principal Investigator:

Santosh Nair, MD

Winship Cancer Institute - Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Kimberly Homere

404-778-6583kimberly.homere@emory.edu

Principal Investigator:

Conor Steuer, MD

Norton Cancer Institute

Recruiting

Louisville, Kentucky, United States, 40202

Contacts

Jenn Broadway, RN

502-629-2500Jennifer.Broadway@nortonhealthcare.org

Principal Investigator:

John Hamm, MD

Henry Ford Cancer Institute

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Mahmoud Hossami

313-725-7842mhossam1@hfhs.org

Principal Investigator:

Amy Weise, MD

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Lindsey Becker

402-691-5255lbecker@nebraskacancer.com

Principal Investigator:

Ralph Hauke, MD

The University of Texas Health Science Center at Tyler

Recruiting

Tyler, Texas, United States, 75701

Contacts

Chaney Story

Chaney.Story@uttyler.edu

Principal Investigator:

Erminia Massarelli, MD, PhD, MS

More Information

Sponsor

Inhibrx Biosciences, Inc

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • 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
  • Neoadjuvant
  • Adjuvant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Inhibrx Biosciences, Inc on 2026-07-29.