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IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
RECRUITINGPhase 1/2Sponsored by Indapta Therapeutics, INC.
Actively Recruiting
PhasePhase 1/2
SponsorIndapta Therapeutics, INC.
Started2023-10-25
Est. completion2025-12-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations12 sites
View on ClinicalTrials.gov →
NCT06119685
Summary
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
Age: 18 Years+Healthy volunteers accepted
Key Inclusion Criteria: * For MM patients: Documented diagnosis of MM requiring systemic therapy and relapsed and/or refractory (R/R) disease after ≥ 3 prior lines of therapy. * For NHL patients: R/R disease and failed ≥ 2 lines of systemic chemotherapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Life expectancy of greater than 12 weeks per the Investigator. Key Exclusion Criteria: * Impaired cardiac function or history of clinical significant cardiac disease. * Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection. * Active SARS-CoV-2 infection. * Has untreated central nervous system, epidural tumor metastasis, or brain metastasis.
Conditions8
Blood CancerCancerMultiple MyelomaNHLRefractory Multiple MyelomaRefractory Non-Hodgkin LymphomaRelapsed Multiple MyelomaRelapsed Non-Hodgkin Lymphoma
Interventions8
Locations12 sites
Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center
University of Minnesota
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Actively Recruiting
PhasePhase 1/2
SponsorIndapta Therapeutics, INC.
Started2023-10-25
Est. completion2025-12-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations12 sites
View on ClinicalTrials.gov →
NCT06119685