RECRUITING

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

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Conditions

NHLMultiple MyelomaBlood CancerRefractory Non-Hodgkin LymphomaRelapsed Non-Hodgkin LymphomaRefractory Multiple MyelomaRelapsed Multiple MyelomaAdvanced Hematologic Cancers

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-10-25
Study Completion:2029-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06119685

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * For MM patients: Documented diagnosis of MM requiring systemic therapy and relapsed and/or refractory (R/R) disease after ≥ 3 prior lines of therapy.
  2. * For NHL patients: R/R disease and failed ≥ 2 lines of systemic chemotherapy.
  3. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  4. * Life expectancy of greater than 12 weeks per the Investigator.
  1. * Impaired cardiac function or history of clinical significant cardiac disease.
  2. * Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
  3. * Active SARS-CoV-2 infection.
  4. * Has untreated central nervous system, epidural tumor metastasis, or brain metastasis.

Contacts and Locations

Study Contact

Indapta Therapeutics, Inc.
CONTACT
TRIALS@INDAPTA.COM

Principal Investigator

Indapta Therapeutics, Inc.
STUDY_DIRECTOR
Indapta Therapeutics, INC.

Study Locations (Sites)

Valkyrie Clinical Trials
Los Angeles, California, 90670
United States
Florida Cancer Specialists and Research Institute - Lake Mary Cancer Center
Lake Mary, Florida, 32746
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
NYP/Weill Cornell Medical Center
New York, New York, 10065
United States
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
United States
University Hospitals Cleveland
Cleveland, Ohio, 44106
United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
United States
Rhode Island Hospital
Providence, Rhode Island, 02903
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
NEXT Oncology Virginia
Fairfax, Virginia, 22031
United States

Collaborators and Investigators

Sponsor: Indapta Therapeutics, INC.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-25
Study Completion Date2029-12-31

Study Record Updates

Study Start Date2023-10-25
Study Completion Date2029-12-31

Terms related to this study

Keywords Provided by Researchers

  • Advanced Hematologic Cancers

Additional Relevant MeSH Terms

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