IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

• Status: Recruiting
• Trial end date: 2029-12-31
• Target enrollment: 0
• Participant gender: All

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 daratumumab or rituximab to evaluate the safety, tolerability and preliminary antitumor activity in patients with advanced hematologic cancers.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indapta Therapeutics, INC.
• Treatments: Cyclophosphamide; Daratumumab; Fludarabine; Interleukin-2; Rituximab

Criteria

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.