Lung Cancer Clinical Trial

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

Summary

This is a first-in-human, open-label, non-randomized, 4-part Phase 1 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).

View Eligibility Criteria

Eligibility Criteria

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 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): Subjects with melanoma (all types), HNSCC, G/GEA, RCC, TCC, NSCLC, or MSI-high, TMB-high, MMR-deficient tumors, with 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.
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. Part 4: Combined Positive Score (CPS) ≥ 1% (or Tumor Proportion Score ≥50% for NSCLC; for TMB-high tumors, any TPS% is allowed).
Adequate hematologic, coagulation, hepatic and renal function and ECOG score as defined per protocol.

Select Exclusion Criteria:

Prior exposure to OX40 agonists.
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.
Known or active primary central nervous system (CNS) tumors, leptomeningeal disease and CNS metastases. Exception: Subjects with previously treated, asymptomatic, and clinically stable CNS metastases may be allowed study entry if certain criteria apply.
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.
Treatment with systemic immunosuppressive medications within 4 weeks 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 for Parts 1 and 3. Exceptions as defined in protocol for expansion cohorts will 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, cerebrovascular accident, or other acute uncontrolled heart disease < 3 months; left ventricular ejection fraction (LVEF) < 50%; New York Heart Association (NYHA) Class III or IV congestive heart failure; or uncontrolled hypertension.
Active, hemodynamically significant pulmonary embolism within 3 months 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 is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

333

Study ID:

NCT04198766

Recruitment Status:

Recruiting

Sponsor:

Inhibrx, Inc.

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There are 13 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States More Info
New Patient Services
Contact
800-826-4673
[email protected]
Valkyrie Clinical Trials
Los Angeles California, 90069, United States More Info
Myo Zaw
Contact
[email protected]
Winship Cancer Institute - Emory University
Atlanta Georgia, 30322, United States More Info
Suzanne Scott
Contact
404-778-4083
[email protected]
The University of Chicago Medical Center
Chicago Illinois, 60637, United States More Info
Kimberly Homere, MPH
Contact
773-702-3320
[email protected]
University of Iowa
Iowa City Iowa, 52242, United States More Info
Jordan Harrelson
Contact
319-467-5831
[email protected]
Norton Cancer Institute
Louisville Kentucky, 40202, United States More Info
Jade Alexander, RN
Contact
502-629-2500
[email protected]
Henry Ford Cancer Institute
Detroit Michigan, 48202, United States More Info
Sonia Carillo
Contact
313-556-8124
[email protected]
START Midwest
Grand Rapids Michigan, 49546, United States More Info
Katie Robinson
Contact
616-389-1739
[email protected]
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States More Info
Josh Settlemire, MSN
Contact
531-329-3651
[email protected]
Providence Cancer Institute
Portland Oregon, 97213, United States More Info
Tara Foote
Contact
503-215-7192
[email protected]
NEXT Oncology
San Antonio Texas, 78229, United States More Info
Kayla Dotson
Contact
210-595-5670
[email protected]
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States More Info
Alexander Spira, MD
Contact
[email protected]
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States More Info
Cassie Kujawa
Contact
414-805-8839
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 1

Estimated Enrollment:

333

Study ID:

NCT04198766

Recruitment Status:

Recruiting

Sponsor:


Inhibrx, Inc.

How clear is this clinincal trial information?

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