NCT06119685 IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
| NCT ID | NCT06119685 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Indapta Therapeutics, INC. |
| Condition | NHL |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2023-10-25 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 128 participants in total. It began in 2023-10-25 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Indapta Therapeutics, Inc.
✉ TRIALS@INDAPTA.COMIndapta Therapeutics, Inc.
STUDY DIRECTOR
Indapta Therapeutics, INC.
Frequently Asked Questions
Who can join the NCT06119685 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NHL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06119685 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06119685 currently recruiting?
Yes, NCT06119685 is actively recruiting participants. Contact the research team at TRIALS@INDAPTA.COM for enrollment information.
Where is the NCT06119685 trial being conducted?
This trial is being conducted at Los Angeles, United States, Lake Mary, United States, Atlanta, United States, Minneapolis, United States and 8 additional locations.
Who is sponsoring the NCT06119685 clinical trial?
NCT06119685 is sponsored by Indapta Therapeutics, INC.. The principal investigator is Indapta Therapeutics, Inc. at Indapta Therapeutics, INC.. The trial plans to enroll 128 participants.