Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
California
Valkyrie Clinical Trials
RECRUITING
Los Angeles
Florida
Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center
WITHDRAWN
Lake Mary
Georgia
Emory University Hospital
RECRUITING
Atlanta
Minnesota
University of Minnesota
RECRUITING
Minneapolis
North Carolina
Atrium Health Wake Forest Baptist
RECRUITING
Winston-salem
New York
NYP/Weill Cornell Medical Center
WITHDRAWN
New York
Ohio
University Hospitals Cleveland
RECRUITING
Cleveland
Oregon
Providence Cancer Institute Franz Clinic
WITHDRAWN
Portland
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Tennessee
SCRI Oncology Partners
RECRUITING
Nashville
Texas
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Virginia
NEXT Oncology Virginia
RECRUITING
Fairfax
Contact Information
Primary
Indapta Therapeutics, Inc.
TRIALS@INDAPTA.COM
Time Frame
Start Date: 2023-10-25
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 128
Treatments
Experimental: Phase 1: Single Agent IDP-023 - Single Dose
NHL or MM patient treated with a single dose of IDP-023 monotherapy
Experimental: Phase 1: Single Agent IDP-023 - Multiple Doses
NHL and MM patients treated with multiple doses of IDP-023 monotherapy
Experimental: Phase 1: Single Agent IDP-023 - Multiple Doses with IL-2
NHL and MM patients treated with multiple doses of IDP-023 monotherapy
Experimental: Phase 2: Combination IDP-023 plus rituximab
NHL patients treated with multiple doses of IDP-023 in combination with rituximab
Experimental: Phase 2: Combination IDP-023 plus daratumumab
MM patients treated with multiple doses of IDP-023 in combination with daratumumab
Experimental: Phase 2: Combination IDP-023 plus isatuximab
MM patients treated with multiple doses of IDP-023 in combination with isatuximab
Related Therapeutic Areas
Sponsors
Leads: Indapta Therapeutics, INC.