IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
Indapta Therapeutics, INC.
128 participants
Oct 25, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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.
Exclusion Criteria4
- 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.
Interventions
NK cell therapy
Anti-CD20 antibody therapy
Anti-CD38 antibody therapy
Immune cytokine
Lymphodepleting chemotherapy
Lymphodepleting chemotherapy
Chemoprotectant
Anti-CD38 antibody therapy
Locations(12)
View Full Details on ClinicalTrials.gov
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NCT06119685