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Official Title
Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
Phase
Phase 1/Phase 2
Sponsor
Indapta Therapeutics, INC.
Enrollment
128
Timeline
Oct 2023 → Dec 2029
About This Study
This is an open label, Phase 1/2, first-in-human, multiple ascending dose, and dose-expansion study of IDP-023 administered as a single agent and in combination with or without interleukin-2 (IL-2), and with or without isatuximab, daratumumab or rituximab to evaluate the safety, tolerability and preliminary antitumor activity in patients with advanced hematologic cancers.
Eligibility Criteria
Inclusion Criteria
- 1For MM patients: Documented diagnosis of MM requiring systemic therapy and relapsed and/or refractory (R/R) disease after ≥ 3 prior lines of therapy.
- 2For NHL patients: R/R disease and failed ≥ 2 lines of systemic chemotherapy.
- 3Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 4Life expectancy of greater than 12 weeks per the Investigator.
Exclusion Criteria
- 1Impaired cardiac function or history of clinical significant cardiac disease.
- 2Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
- 3Active SARS-CoV-2 infection.
- 4Has untreated central nervous system, epidural tumor metastasis, or brain metastasis.
Locations
12 sites participating in this study
Emory University Hospital
Atlanta, Georgia 30322
Valkyrie Clinical Trials
Los Angeles, California 90670
Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center
Lake Mary, Florida 32746
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →