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

Description

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.

Conditions

NHL, Multiple Myeloma, Blood Cancer, Refractory Non-Hodgkin Lymphoma, Relapsed Non-Hodgkin Lymphoma, Refractory Multiple Myeloma, Relapsed Multiple Myeloma

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Study Overview

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Study Details

Study overview

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.

Phase 1/2 Study of IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

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

Condition
NHL
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Valkyrie Clinical Trials, Los Angeles, California, United States, 90670

Lake Mary

Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center, Lake Mary, Florida, United States, 32746

Atlanta

Emory University Hospital, Atlanta, Georgia, United States, 30322

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

New York

NYP/Weill Cornell Medical Center, New York, New York, United States, 10065

Winston-Salem

Atrium Health Wake Forest Baptist, Winston-Salem, North Carolina, United States, 27157

Cleveland

University Hospitals Cleveland, Cleveland, Ohio, United States, 44106

Portland

Providence Cancer Institute Franz Clinic, Portland, Oregon, United States, 97213

Providence

Rhode Island Hospital, Providence, Rhode Island, United States, 02903

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Indapta Therapeutics, INC.,

Indapta Therapeutics, Inc., STUDY_DIRECTOR, Indapta Therapeutics, INC.

Study Record Dates

2029-12-31