Phase 1 Study of INBRX-109 in Subjects with Locally Advanced or Metastatic Solid Tumors Including Sarcomas
Trial Status: active
This is a first-in-human, open-label, non-randomized, three-part phase 1 trial of INBRX-109, which is a recombinant humanized tetravalent antibody targeting the human death receptor 5 (DR5).
Inclusion Criteria
- Males or females aged ≥12 to less than 85 years for Ewing sarcoma and 18 to less than 85 years of age for other tumors.
- Part 3 combination therapy expansion tumor types:
- Histologically confirmed Ewing sarcoma with a classical fusion: Patients with locally advanced or metastatic, unresectable, relapsed, or refractory disease who have received at least 1 but no more than 2 prior lines of systemic treatment with a preferred first line chemotherapy regimens.
- Colorectal adenocarcinoma: Patients with locally advanced or metastatic, unresectable disease, who have received at least 2 but no more than 3 prior lines of systemic therapy.
- Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria.
- Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1, or Karnofsky Performance Status score of ≥60, or Lansky Play-Performance Scale for Children score ≥60 (for patients less than 16 years).
- Estimated life expectancy of at least 12 weeks.
- Availability of archival tissue or fresh cancer biopsy are mandatory.
Exclusion Criteria
- Prior treatment with or exposure to DR5 agonists.
- Receipt of any anticancer therapy (including investigational agents) within 4 weeks or within 5 half-lives prior to the first dose of study treatment. Exceptions per protocol.
- Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
- Receipt of radiotherapy within 4 weeks prior to the first dose of study treatment, and liver-directed within 12 months prior to the first dose of study drug.
- Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exceptions per protocol.
- Prior or concurrent malignancies. Exceptions per protocol.
- Hematologic malignancies.
- Symptomatic active primary CNS tumors, leptomeningeal disease, and CNS metastases. Exceptions per protocol. Patients with any evidence or history of multiple sclerosis (MS) or other demyelinating disorders are excluded.
- Chronic liver diseases including fatty liver. Exception: Patients < 45 years old with fatty liver disease may be accepted as long as adequate hepatic function as defined in the inclusion/exclusion criteria is confirmed.
- Acute viral or toxic liver disease within 12 months prior to the first dose of study drug.
- Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
- Known sensitivity or contraindications to the following drugs:
- Ewing sarcoma: irinotecan or TMZ
- colorectal adenocarcinoma: FU, leucovorin, or irinotecan
- Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease less than 3 months prior to enrollment.
- Acute, hemodynamically significant deep vein thrombosis or clinically significant pulmonary embolism not resolved or stable for at least 3 months prior to the start of study treatment.
- Major surgery within 4 weeks prior to enrollment on this trial.
- Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug.
- Other exclusion criteria per protocol.
Additional locations may be listed on ClinicalTrials.gov for NCT03715933.
Locations matching your search criteria
United States
California
Duarte
City of Hope Comprehensive Cancer Center
Status: Active
Name Not AvailableSan Francisco
University of California San Francisco
Status: Active
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu
Colorado
Aurora
UCHealth University of Colorado Hospital
Status: Active
Contact: Sierra Moriuchi
Phone: 720-848-1386
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
Status: Active
Name Not AvailableMichigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: Active
Name Not AvailableNew York
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Name Not AvailableOhio
Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not AvailableOregon
Portland
OHSU Knight Cancer Institute
Status: Active
Name Not AvailablePennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer Center
Status: Active
Name Not AvailableTennessee
Nashville
Vanderbilt University/Ingram Cancer Center
Status: Active
Name Not AvailableTexas
Houston
M D Anderson Cancer Center
Status: Active
Name Not AvailableVirginia
Charlottesville
University of Virginia Cancer Center
Status: Active
Name Not AvailableTrial PhasePhase I
Trial Typetreatment
Lead OrganizationInhibrx Biosciences, Inc
- Primary IDPh1 INBRX-109
- Secondary IDsNCI-2018-03556
- ClinicalTrials.gov IDNCT03715933