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

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

INTRODUCTION

  • Org Study ID: Ph 1 Ph 2 INBRX-106
  • Secondary ID: N/A
  • NCT ID: NCT04198766
  • Sponsor: Inhibrx Biosciences, Inc

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.

  • Overall Status
    Recruiting
  • Start Date
    December 10, 2019
  • Phase
    PHASE1, PHASE2
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Frequency of adverse events of INBRX-106 as single agent and in combination with pembrolizumab

Primary Outcome 1 - Timeframe: ~2 years

Primary Outcome 2 - Measure: Severity of adverse events of INBRX-106 as single agent and in combination with pembrolizumab

Primary Outcome 2 - Timeframe: ~2 years

Primary Outcome 3 - Measure: MTD and/or RP2D of INBRX-106 as single agent and in combination with pembrolizumab

Primary Outcome 3 - Timeframe: ~2 years

Primary Outcome 4 - Measure: Antitumor activity of INBRX-106 in combination with pembrolizumab in expansion cohorts

Primary Outcome 4 - Timeframe: ~2 years

Primary Outcome 5 - Measure: Frequency and severity of adverse events of INBRX-106 in combination with pembrolizumab and chemotherapy in adults with locally advanced or metastatic NSCLC

Primary Outcome 5 - Timeframe: ~2 years

CONDITION

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

ELIGIBILITY

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.

- * 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).

- * 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 active central nervous system (CNS) metastases and/or carcinomatous meningitis. Exception: Subjects who are previously treated and are radiologically and clinically stable without the requirement for steroid treatment for at least 14 days prior to first dose of study treatment 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.

- * 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, 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; or oxygen saturation <92% on room air. - * 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Clinical Lead

Role: Study Director

Affiliation: Inhibrx Biosciences, Inc

Overall Contact

Name: Study Director - Inhibrx Biosciences, Inc

Phone: 858-500-7833

Email: [email protected]

LOCATION

Facility Status Contact
Facility: City of Hope
Duarte, California 91010
United States
Status: Recruiting Contact: Contact
New Patient Services
800-826-4673
[email protected]

Principal Investigator
Erminia Massarelli, MD

Facility: Valkyrie Clinical Trials
Los Angeles, California 90069
United States
Status: Recruiting Contact: Contact
Myo Zaw
[email protected]

Principal Investigator
David Berz, MD

Facility: Winship Cancer Institute - Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Suzanne Scott
404-778-4083
[email protected]

Principal Investigator
Conor Steuer, MD

Facility: The University of Chicago Medical Center
Chicago, Illinois 60637
United States
Status: Recruiting Contact: Contact
Cristina Chivato
773-834-2419
[email protected]

Principal Investigator
Daniel Olson, MD

Facility: University of Iowa
Iowa City, Iowa 52242
United States
Status: Recruiting Contact: Contact
Jordan Harrelson
319-467-5831
[email protected]

Principal Investigator
Muhammad Furqan, MD

Facility: Norton Cancer Institute
Louisville, Kentucky 40202
United States
Status: Recruiting Contact: Contact
Rebecca Gash, RN
502-629-2500
19535
[email protected]

Principal Investigator
John Hamm, MD

Facility: Henry Ford Cancer Institute
Detroit, Michigan 48202
United States
Status: Recruiting Contact: Contact
Andrew Anastos
[email protected]

Principal Investigator
Amy Weise, MD

Facility: START Midwest
Grand Rapids, Michigan 49546
United States
Status: Recruiting Contact: Contact
Julie Burns
616-954-5559
[email protected]

Principal Investigator
Manish Sharma, MD

Facility: Nebraska Cancer Specialists
Omaha, Nebraska 68130
United States
Status: Recruiting Contact: Contact
Josh Settlemire, MSN
531-329-3651
[email protected]

Principal Investigator
Ralph Hauke, MD

Facility: Providence Portland Medical Center
Portland, Oregon 97213
United States
Status: Recruiting Contact: Contact
Alaina Randerson
503-215-7192
[email protected]

Principal Investigator
Rachel Sanborn, MD

Facility: Vanderbilt University School of Medicine
Nashville, Tennessee 37204
United States
Status: Recruiting Contact: Contact
Starlee Hutchings
615-421-8270
[email protected]

Principal Investigator
Elizabeth Davis, MD

Facility: Renovatio Clinical - El Paso
El Paso, Texas 79915
United States
Status: Recruiting Contact: Contact
Maritza Seanez
[email protected]

Principal Investigator
Haroutioun Shahinian, MD

Facility: Renovatio Clinical
The Woodlands, Texas 77380
United States
Status: Recruiting Contact: Contact
Pablo Villarreal
[email protected]

Principal Investigator
Jonathan Lu, MD

Facility: Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: Contact
Janice Alcaide, MD
[email protected]

Principal Investigator
Alexander Spira, MD

Facility: Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Status: Recruiting Contact: Contact
Colleen Cotter
[email protected]

Principal Investigator
Jonathan Thompson, MD