Actively Recruiting
A Phase 1/2 Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies
Led by IDP Discovery Pharma S.L. · Updated on 2025-05-01
37
Participants Needed
11
Research Sites
145 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Phase 1/2 Study of IDP-121 in Patients With Relapsed/Refractory Hematologic Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ECOG performance status of 2 or less
- Life expectancy of at least 3 months
- Willing and able to follow study requirements
- Provided written informed consent
- Diagnosed with chronic lymphocytic leukemia, B-cell lymphomas, or multiple myeloma and ineligible for available treatments
- Adequate blood and biochemical parameters including hemoglobin > 8.0 g/dl, platelets count > 75 x109/L (or > 50 x109/L with bone marrow infiltration), ANC > 0.75 x109/L, AST and ALT less than specified limits, total bilirubin < 2 times upper limit, creatinine clearance > 30 mL/min
- Left ventricular ejection fraction > 50% or above institutional lower limit of normal
You will not qualify if you...
- Persistent significant non-hematological toxicity from previous treatments (except mild alopecia or peripheral neuropathy grade <2)
- Pregnant or breastfeeding women; men and women of reproductive potential not using effective contraception
- History of other cancers within 5 years except certain skin cancers
- History of clinically significant low blood pressure
- History of significant allergic or hypersensitivity reactions
- History or high risk of vascular diseases including thromboembolism, peripheral arterial disease, or vasculitis
- Congestive heart failure, angina, or recent myocardial infarction within 12 months
- Uncontrolled high blood pressure or cardiac arrhythmias requiring recent medication changes or hospitalization
- Significant neurological or psychiatric disorders
- Active or significant infections
- Significant liver disease such as cirrhosis or active hepatitis
- HIV positive without controlled viral load or active hepatitis B, C, or CMV infections
- Recent anti-tumor therapy within 14 days before study treatment
- Recent allogeneic transplant or active graft-versus-host disease with immunosuppression
- Unable to comply with treatment or follow-up
- COVID-19 vaccine administered less than 72 hours before treatment start or during dose-limiting toxicity period in dose-escalation phase
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Actively Recruiting
2
Hospital Universitario de Salamanca
Salamanca, Castille and León, Spain, 37007
Actively Recruiting
3
Hospital Universitari Vall d'hebron
Barcelona, Spain, 08035
Actively Recruiting
4
Hospital Durán i Reynals - ICO L´Hospitalet
Barcelona, Spain
Actively Recruiting
5
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
6
Hospital Universitario La Paz
Madrid, Spain
Actively Recruiting
7
Hospital Universitario Puerta de Hierro
Madrid, Spain
Actively Recruiting
8
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Spain, 30120
Actively Recruiting
9
Hospital Universitario Virgen del Rocio
Seville, Spain
Actively Recruiting
10
Hospital de Clinico Universitario de Valencia
Valencia, Spain
Actively Recruiting
11
Hospital Universitario Miguel Servet
Zaragoza, Spain
Actively Recruiting
Research Team
D
David Molina, PhD
CONTACT
L
Laura Nevola, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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