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Brief Title: Study of INBRX-105 in Patients With Solid Tumors, Hodgkin or Non-Hodgkin Lymphoma

An Open-Label, Multicenter, First-in-Human, Dose-Escalation, Phase 1 Study of INBRX-105 and INBRX-105 in Combination With Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

INTRODUCTION

  • Org Study ID: Ph 1 INBRX-105
  • Secondary ID: N/A
  • NTC ID: NCT03809624
  • Sponsor: Inhibrx, Inc.

BRIEF SUMMARY

This is a first-in-human, open-label, nonrandomized, four-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-105 and INBRX-105 in combination with Pembrolizumab. INBRX-105, a next generation bispecific antibody, targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor. INBRX-105 provides localized conditional T-cell co-stimulation through 4-1BB agonism.

  • Overall Status
    Recruiting
  • Start Date
    January 30, 2019
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Frequency of adverse events of INBRX-105

Primary Outcome 1 - Timeframe: Up to 2-3 years

Primary Outcome 2 - Measure: Severity of adverse events of INBRX-105

Primary Outcome 2 - Timeframe: Up to 2-3 years

Primary Outcome 3 - Measure: Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of INBRX-105

Primary Outcome 3 - Timeframe: Up to 2-3 years

CONDITION

  • Metastatic Solid Tumors
  • Non-small Cell Lung Cancer
  • Melanoma
  • Head and Neck Squamous Cell Carcinoma
  • Gastric Adenocarcinoma
  • Renal Cell Carcinoma
  • Urothelial Carcinoma
  • Esophageal Adenocarcinoma

ELIGIBILITY

Inclusion Criteria:
Parts 1 and 3 (escalation cohorts): Patients with locally advanced or metastatic non-resectable solid tumors, whose disease has progressed despite standard therapy and for whom no further standard therapy exists.

- Parts 2 and 4 (expansion cohorts): Patients with non-small cell lung cancer, melanoma, head and neck squamous cell carcinoma, gastric or gastro-esophageal junction adenocarcinoma, renal cell carcinoma, or urothelial (transitional) cell carcinoma, with locally advanced or metastatic, non-resectable disease, which has progressed despite standard therapy or for whom no standard or clinically acceptable therapy exists.

- Part 4 treatment naive NSCLC cohort: Locally advanced or metastatic, non-resectable NSCLC, who have not received prior systemic treatment, including CPI, for advanced or metastatic disease. PD-L1 IHC Tumor Proportion Score (TPS) ≥ 1% and < 50%. In Part 4, all patients with non-squamous NSCLC must have documentation of absence of tumor activating EGFR mutations and absence of ALK gene rearrangements. - Refractory or relapsed to anti-PD-1 or anti-PD-L1, and anti-CTLA4 if applicable (NOTE: For all tumor types with checkpoint inhibitor approvals) with exception of the treatment naive NSCLC cohort. - PD-L1 positivity by immunohistochemistry (IHC): Parts 1 and 3 (escalation cohorts) PD-L1 positivity is not required. Parts 2 and 4 (expansion cohorts): Combined Positive Score (CPS) or Tumor Proportion Score (TPS) above certain thresholds as defined per protocol. - Adequate hematologic, coagulation, hepatic and renal function as defined per protocol. - Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
Exclusion Criteria:
Prior exposure to 4-1BB 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. Exceptions: Hormone replacement therapy, testosterone, or oral contraceptives. NOTE: Previous exposure to anti-PD-L1 checkpoint inhibitor requires a minimum washout period of 24 weeks prior to the first dose of study drug.

- Hematologic malignancies (e.g., ALL, AML, MDS, CLL, CML, NHL, Hodgkin 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-105.

- 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 Part 1. Exceptions as defined in protocol for expansion cohorts will apply.

- History of hepatitis or cirrhosis (e.g., non-alcohol steatohepatitis, alcohol or drug-related, autoimmune, hepatitis B, or hepatitis C) for Part 1. 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.

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: HonorHealth Research Institute
Scottsdale, Arizona 85258
United States
Status: Recruiting Contact: Contact
Joyce Schaffer
480-323-1791
jschaffner@honorhealth.com
Facility: City of Hope
Duarte, California 91010
United States
Status: Recruiting Contact: Principal Investigator
Tsai Frank, MD
626-218-0979
sthiagarajan@coh.org
Facility: University of Colorado Health Sciences Center
Aurora, Colorado 80045
United States
Status: Recruiting Contact: Contact
Shamili Thiagarajan
720-848-4394
ana.nguyen@cuanschutz.edu
Facility: Emory University - Winship Cancer Institute
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Ana Nguyen
404-778-4083
suzanne.e.scott@emory.edu
Facility: Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Status: Recruiting Contact: Principal Investigator
Ross Camidge, MD
616-389-1739
jpark73@mgh.harvard.edu
Facility: START Midwest
Grand Rapids, Michigan 49546
United States
Status: Recruiting Contact: Contact
Suzanne Scott
215-662-7179
Katie.Robinson@startmidwest.com
Facility: Abramson Cancer Center - University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: Contact
Park Jong Chul, MD
713-745-9143
James.Phillips@pennmedicine.upenn.edu
Facility: MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Principal Investigator
Jong Chul Park, MD
210-580-9521
FFaiz@mdanderson.org
Facility: NEXT Oncology
San Antonio, Texas 78229
United States
Status: Recruiting Contact: Contact
Katie Robinson

cdeleon@nextoncology.com