Phase 12 Study of IDP-121 Treatment in Adults With Relapsed or Resistant Blood Cancers Including Multiple Myeloma and Lymphomas

What this Trial Is About

Researchers are evaluating IDP-121, a new drug targeting the cMyc protein, in patients with relapsed or refractory blood cancers including multiple myeloma, diffuse large B-cell lymphoma, high-grade B-cell lymphomas, and chronic lymphocytic leukemia. This open-label, multicenter Phase 12 study aims first to find the highest safe dose and recommended dose for further study, then to assess how well patients respond to the drug and how long those responses last. In the Phase 1 dose-escalation phase, patients receive IDP-121 by 4-hour intravenous infusion twice weekly on specific days within 28-day cycles. Doses start low and increase based on safety and tolerance, with monitoring for dose-limiting toxicities during the first treatment cycle. Once the recommended Phase 2 dose is identified, additional patients enter the expansion phase to further assess safety and effectiveness, receiving treatment for up to 12 cycles or until progression or unacceptable side effects. Participants will undergo regular monitoring including blood tests, heart function assessments, and evaluations of their disease status throughout treatment. Researchers will measure outcomes such as overall response rate, duration of response, and progression-free survival. The study allows treatment to continue up to one year, with careful tracking of safety and disease progression, aiming to gather comprehensive data on IDP-121s impact in these blood cancers.

A Phase 1/2 Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies