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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 2 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 2 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 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 2
  • 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
  • Nasopharyngeal Carcinoma
  • Oropharyngeal Carcinoma

ELIGIBILITY

Inclusion Criteria:
Parts 1 and 3 (escalation cohorts; completed): 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.

- Part 2 (expansion cohorts): Patients with non-small cell lung cancer, cutaneous melanoma, head and neck squamous cell carcinoma or solid tumors amenable to paired biopsies, 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 relapsed or refractory to CPI cohorts: NSCLC, cutaneous melanoma, HNSCC, MSI/TMB-high or MMRd solid tumors

- Part 4 CPI naive cohorts: locally advanced or metastatic, non-resectable NSCLC or HNSCC

- 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). 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). 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: Vasily Andrianov, MD

Role: Study Director

Affiliation: Inhibrx, Inc.

Overall Contact

Name: Vasily Andrianov, MD

Phone: 858-500-7833

Email: clinicaltrials@inhibrx.com, clinicaltrials@inhibrx.com

LOCATION

Facility Status Contact
Facility: HonorHealth Research Institute
Scottsdale, Arizona 85258
United States
Status: Recruiting Contact: Contact
Joyce Schaffer
480-323-1791 19535
jschaffner@honorhealth.com
Facility: City of Hope
Duarte, California 91010
United States
Status: Recruiting Contact: Principal Investigator
Tsai Frank, MD
626-218-0979 1515
sthiagarajan@coh.org
Facility: Valkyrie Clinical Trials
Los Angeles, California 90069
United States
Status: Recruiting Contact: Contact
Shamili Thiagarajan
310-905-6791
myo.zaw@valkyrieclinicaltrials.com
Facility: Emory University - Winship Cancer Institute
Atlanta, Georgia 30322
United States
Status: Recruiting Contact: Contact
Myo Zaw
404-778-4083
suzanne.e.scott@emory.edu
Facility: Norton Cancer Center
Louisville, Kentucky 40202
United States
Status: Recruiting Contact: Contact
Suzanne Scott
502-629-2500
Jade.Alexander@nortonhealthcare.org
Facility: Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Status: Recruiting Contact: Contact
Jade Alexander, RN
616-389-1739
jpark73@mgh.harvard.edu
Facility: START Midwest
Grand Rapids, Michigan 49546
United States
Status: Recruiting Contact: Contact
Park Jong Chul, MD
531-329-3651
Katie.Robinson@startmidwest.com
Facility: Nebraska Cancer Specialists
Omaha, Nebraska 68130
United States
Status: Recruiting Contact: Principal Investigator
Jong Chul Park, MD
503-215-7192
Jsettlemire@nebraskacancer.com
Facility: Providence Cancer Institute
Portland, Oregon 97213
United States
Status: Recruiting Contact: Contact
Katie Robinson
215-662-7179
tara.foote@providence.org
Facility: Abramson Cancer Center - University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Status: Recruiting Contact: Contact
Josh Settlemire
713-794-1751
James.Phillips@pennmedicine.upenn.edu
Facility: MD Anderson Cancer Center
Houston, Texas 77030
United States
Status: Recruiting Contact: Contact
Tara Foote, RN
801-590-8520
ALui@mdanderson.org
Facility: START Mountain Region
West Valley City, Utah 84119
United States
Status: Recruiting Contact: Contact
James Phillips

marianne.herndon@startthecure.com
Facility: Virginia Cancer Specialists
Fairfax, Virginia 22031
United States
Status: Recruiting Contact: Contact
Anna Lui