RecruitingPhase 1Phase 2NCT05908409

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

A Phase 1/2 Multicenter, Open-label, Dose-escalation Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies (CASSANDRA)


Sponsor

IDP Discovery Pharma S.L.

Enrollment

37 participants

Start Date

Jun 5, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The main aims of this 2-part study are: * Phase I: To determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IDP-121 in patients with multiple myeloma (MM), diffuse large B cell lymphoma not otherwise specified (DLBCL-NOS), high-grade B cell lymphoma with double or triple hit rearrangement (HGBL-DH/TH) and HGBL-NOS, and chronic lymphocytic leukemia (CLL). * Phase II: To evaluate the overall response rate (ORR), duration of response (DoR), time to progression (TTP), progression-free survival (PFS), event-free survival (EFS) and Overall survival (OS), in patients with MM, DLBCL-NOS, HGBL-DH/TH, HGBL-NOS or CLL treated with IDP-121 at the recommended Phase 2 Dose (RP2D).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new drug called IDP-121 in people with blood cancers — specifically chronic lymphocytic leukemia (CLL), B-cell lymphomas, and multiple myeloma — who have already tried other treatments and have run out of standard options. **You may be eligible if...** - You are 18 or older with CLL, B-cell lymphoma, or multiple myeloma - You are no longer eligible for available standard treatments - You have a life expectancy of at least 3 months - Your blood counts and organ function are within acceptable ranges - Your heart function is adequate (ejection fraction above 50%) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had another cancer in the past 5 years (excluding minor skin cancers) - You have HIV (unless on effective treatment with undetectable viral load), active hepatitis B or C - You have a history of significant blood vessel disease (clots, peripheral artery disease, vasculitis) - You have significant heart disease or uncontrolled high blood pressure - You had a bone marrow/stem cell transplant in the past 3 months or have active graft-versus-host disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIDP-121

IDP-121 is a new chemical entity specifically designed to directly target cMyc protein that has demonstrated activity in multiple liquid and solid tumor cell lines and preclinical animal models


Locations(11)

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario de Salamanca

Salamanca, Castille and León, Spain

Hospital Universitari Vall d'hebron

Barcelona, Spain

Hospital Durán i Reynals - ICO L´Hospitalet

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Puerta de Hierro

Madrid, Spain

Hospital Clínico Universitario Virgen de la Arrixaca

Murcia, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Hospital de Clinico Universitario de Valencia

Valencia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

View Full Details on ClinicalTrials.gov

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NCT05908409


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