Back to Trials
NCT04198766PHASE1, PHASE2Recruiting

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

Inhibrx Biosciences, Inc

Start Date

12/10/2019

Completion Date

7/1/2033

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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

INBRX-106 - Hexavalent OX40 agonist antibody

DRUG

pembrolizumab 200 mg

DRUG

pembrolizumab 400 mg

DRUG

Carboplatin AUC-5

DRUG

Carboplatin AUC-6

DRUG

Pemetrexed 500 mg/m2

DRUG

Cisplatin 75mg/m2

DRUG

Paclitaxel 200mg/m2

DRUG

Nab paclitaxel 100mg/m2

DRUG

Gemcitabine (1000 mg/m2)

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

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

Locations

City of Hope

Duarte, California 91010

United States

Los Angeles Cancer Network

Glendale, California 91204

United States

California Research Institute

Los Angeles, California 90027

United States

Valkyrie Clinical Trials

Los Angeles, California 90069

United States

Valkyrie Clinical Trials

Murrieta, California 92562

United States

Providence Medical Foundation

Santa Rosa, California 95403

United States

Clermont Oncology Center

Clermont, Florida 34711

United States

Mid Florida Hematology and Oncology Center

Orange City, Florida 32763

United States

Winship Cancer Institute - Emory University

Atlanta, Georgia 30322

United States

The University of Chicago Medical Center

Chicago, Illinois 60637

United States

University of Iowa

Iowa City, Iowa 52242

United States

Norton Cancer Institute

Louisville, Kentucky 40202

United States

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan 48201

United States

Henry Ford Cancer Institute

Detroit, Michigan 48202

United States

START Midwest

Grand Rapids, Michigan 49546

United States

HealthPartners Cancer Research Center

Saint Louis Park, Minnesota 55426

United States

HealthPartners Cancer Research Center (Regions Hospital)

Saint Paul, Minnesota 55101

United States

Intermountain Health Cancer Centers of Montana

Billings, Montana 59102

United States

Nebraska Cancer Specialists

Omaha, Nebraska 68130

United States

Montefiore Medical Center

The Bronx, New York 10467

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

Providence Portland Medical Center

Portland, Oregon 97213

United States

Vanderbilt University School of Medicine

Nashville, Tennessee 37204

United States

Sarah Cannon Research Institute at Mary Crowley

Dallas, Texas 75230

United States

Renovatio Clinical - El Paso

El Paso, Texas 79915

United States

NEXT Oncology

San Antonio, Texas 78229

United States

Renovatio Clinical

The Woodlands, Texas 77380

United States

The University of Texas Health Science Center at Tyler

Tyler, Texas 75701

United States

Virginia Cancer Specialists

Fairfax, Virginia 22031

United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin 53226

United States

Curie Oncology

Singapore,

Singapore

Icon Cancer Centre Farrer Park

Singapore,

Singapore

Icon Cancer Centre Mount Alvernia

Singapore,

Singapore

The Catholic University of Korea, St. Vincent's Hospital

Gyeonggi-do,

South Korea

Asan Medical Center

Seoul,

South Korea

Severance Hospital, Yonsei University Health System

Seoul,

South Korea

The Catholic University of Korea Seoul St. Mary's Hospital,

Seoul,

South Korea

Changhua Christian Hospital (CCH)

Changhua,

Taiwan

E-Da Cancer Hospital

Kaohsiung City,

Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)

Kaohsiung City,

Taiwan

National Cheng Kung University Hospital

Tainan,

Taiwan

Taipei Veterans General Hospital

Taipei,

Taiwan