Actively Recruiting
A Phase 1/2 Multicenter, Open-label, Dose-escalation 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
12 weeks
Total Duration
On this page
AI-Summary
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 1/2 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-121's impact in these blood cancers.
CONDITIONS
Brief 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
- Performance status (ECOG) of 2 or less
- Life expectancy of at least 3 months
- Willing and able to comply with study requirements
- Provided voluntary written informed consent
- Diagnosed with chronic lymphocytic leukemia, B-cell lymphomas, or multiple myeloma and ineligible for available treatments
- Adequate blood counts: hemoglobin > 8.0 g/dl, platelets > 75 x10^9/L (or > 50 x10^9/L with bone marrow infiltration), absolute neutrophil count > 0.75 x10^9/L
- Adequate liver function: AST and ALT below specified limits depending on liver metastases, 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-blood toxicity from previous treatments, except mild alopecia or grade <2 peripheral neuropathy
- Pregnant or lactating women; men and women of reproductive potential not using effective contraception
- History of other cancers in last 5 years except certain skin cancers
- History of clinically significant low blood pressure
- History of severe allergic or hypersensitivity reactions
- History or risk of vascular diseases including thromboembolism, peripheral arterial disease, or vasculitis
- Congestive heart failure, recent heart attack, uncontrolled hypertension, or cardiac arrhythmias
- Significant neurological or psychiatric disorders
- Active or significant infections
- Significant liver disease such as cirrhosis or chronic hepatitis
- Known HIV positive unless under antiviral therapy with low viral load; active hepatitis B or C unless treated
- Anti-tumor therapy within 14 days before study start
- Recent allogeneic transplant or active graft-versus-host disease requiring immunosuppression
- Inability to comply with treatment or follow-up
- COVID-19 vaccine administered within 72 hours before treatment 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months or until discontinuation
Participants receive IDP-121 as a 4-hour intravenous infusion twice a week (3 weeks on, 1 week off) in 28-day cycles. Treatment continues for up to 12 cycles or until disease progression, unacceptable toxicity, or other discontinuation criteria are met.
Twice weekly visits during treatment cycles
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
L
Laura Nevola, PhD
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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