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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, Phase 1 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 INBRX-106
  • Secondary ID: MK3475 KEYNOTE A99
  • NTC ID: NCT04198766
  • Sponsor: Inhibrx, Inc.

BRIEF 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).

  • Overall Status
    Recruiting
  • Start Date
    December 10, 2019
  • Phase
    Phase 1
  • 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: 2-4 years

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

Primary Outcome 2 - Timeframe: 2-4 years

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

Primary Outcome 3 - Timeframe: 2-4 years

CONDITION

  • Solid Tumor
  • Non-Small Cell Lung Cancer
  • Melanoma
  • Head and Neck Cancer
  • 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 locally advanced or metastatic, non-resectable disease, which has progressed despite all standard therapies or for whom no standard or clinically acceptable therapy exists.

- Part 4 (expansion cohorts in combination with pembrolizumab): Subjects with melanoma, HNSCC, G/GEA, RCC, or TCC, or NSCLC, with locally advanced or metastatic, non resectable disease, which has progressed despite all standard therapies 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 ≥1% for NSCLC).

- 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Klaus Wagner, MD, PhD

Role: Study Director

Affiliation: Inhibrx, Inc.

Overall Contact

Name: Klaus Wagner, MD, PhD

Phone: 858-500-7833

Email: terri@inhibrx.com

LOCATION

Facility Status Contact
Facility: City of Hope
Duarte, California 91010
United States
Status: Recruiting Contact: Contact
New Patient Services
800-826-4673
sthiagarajan@coh.org
Facility: Winship Cancer Institute - Emory University
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Suzanne Scott
404-778-4083
suzanne.e.scott@emrory.edu
Facility: The University of Chicago Medical Center
Chicago, Illinois 60637
United States
Status: Recruiting Contact: Contact
Jeffery Chin
773-834-5004
jchin18@medicine.bsd.uchicago.edu
Facility: University of Iowa
Iowa City, Iowa 52242
United States
Status: Recruiting Contact: Contact
Jordan Harrelson
319-467-5831
Jordan-harrelson@uiowa.edu
Facility: START Midwest
Grand Rapids, Michigan 49546
United States
Status: Recruiting Contact: Contact
Katie Robinson
616-389-1739
Katie.Robinson@startmidwest.com
Facility: Nebraska Cancer Specialists
Omaha, Nebraska 68130
United States
Status: Recruiting Contact: Contact
Gladys Pierce
402-691-6972
gpierce@nebraskacancer.com
Facility: Providence Cancer Institute
Portland, Oregon 97213
United States
Status: Recruiting Contact: Contact
Tara Foote
503-215-7192
ORCanClinRsrch@providence.org
Facility: NEXT Oncology
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Kayla Dotson
210-595-5670
kdotson@nextoncology.com