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Official Title
An Open-Label, Multicenter, First-in-Human, Phase 1 Dose-Escalation and Multicohort Expansion Study of INBRX-109 in Subjects With Locally Advanced or Metastatic Solid Tumors Including Sarcomas
Phase
Phase 1
Sponsor
Inhibrx Biosciences, Inc
Enrollment
321
Timeline
Oct 2018 → Dec 2026
About This Study
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).
Eligibility Criteria
Inclusion Criteria
- 1Males or females aged ≥12 to less than 85 years for Ewing sarcoma and 18 to less than 85 years of age for other tumors.
- 2Part 3 combination therapy expansion tumor types:
- 3Histologically 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.
- 4Colorectal 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.
- 5Measurable disease as defined by RECISTv1.1 (or modified RECIST for mesothelioma) criteria.
- 6Adequate hematologic, coagulation, hepatic and renal function as defined per protocol.
- 7Eastern 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).
- 8Estimated life expectancy of at least 12 weeks.
- 9Availability of archival tissue or fresh cancer biopsy are mandatory.
Exclusion Criteria
- 1Prior treatment with or exposure to DR5 agonists.
- 2Receipt 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.
- 3Allergy or sensitivity to INBRX-109 or known allergies to CHO-produced antibodies.
- 4Receipt 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.
- 5Subject has undergone allogeneic hematopoietic stem cell or bone marrow transplantation within the last 5 years. Exceptions per protocol.
- 6Prior or concurrent malignancies. Exceptions per protocol.
- 7Hematologic malignancies.
- 8Symptomatic 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.
- 9Acute viral or toxic liver disease within 12 months prior to the first dose of study drug.
- 10Evidence or history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection.
- 11Known sensitivity or contraindications to the following drugs:
- 12Ewing sarcoma: irinotecan or TMZ
- 13colorectal adenocarcinoma: FU, leucovorin, or irinotecan
- 14Clinically significant cardiac condition, including myocardial infarction, uncontrolled angina, cerebrovascular accident, or other acute uncontrolled heart disease less than 3 months prior to enrollment.
- 15Acute, 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.
- 16Major surgery within 4 weeks prior to enrollment on this trial.
- 17Systemic infection requiring antibiotics within 2 weeks prior to the first dose of study drug.
Locations
35 sites participating in this study
Emory University - Winship Cancer Institute
Atlanta, Georgia 30322
Olatunji Alese, MD
HonorHealth Research Institute
Scottsdale, Arizona 85258
Precision NextGen Oncology and Research
Beverly Hills, California 90212
Kamalesh Sankhala, MD
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →