|

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

Locations12 sites

Valkyrie Clinical Trials
Los Angeles, California, 90670
Myo Zaw626-632-1963myo.zaw@vctcare.com
Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center
Lake Mary, Florida, 32746
Emory University Hospital
Atlanta, Georgia, 30322
University of Minnesota
Minneapolis, Minnesota, 55455
Kayla Wagenmann, MN, RN, PHN612-624-2342wage0074@umn.edu
NYP/Weill Cornell Medical Center
New York, New York, 10065

Browse More Trials

Cancer trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.