About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • IDP-023
  • Rituximab
  • Daratumumab
  • Interleukin-2
  • Cyclophosphamide
  • Fludarabine
  • Mesna
  • Isatuximab

Treatment groups

128 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Locations

12
California
Valkyrie Clinical Trials90670, Los Angeles United States
Florida
Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center32746, Lake Mary United States
Georgia
Emory University Hospital30322, Atlanta United States
Minnesota
University of Minnesota55455, Minneapolis United States

Sponsors and collaborators

Indapta Therapeutics, INC.

Lead sponsor