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
6
Treatment groupsSee each treatment group below.