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Testing IDP-121 in patients with certain blood cancers

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

Phase1; Phase2 Interventional IDP Discovery Pharma S.L. · NCT05908409

This study is testing a new treatment called IDP-121 to see if it can help people with certain blood cancers, like multiple myeloma and lymphoma, feel better and live longer.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment37 (estimated)
Ages18 Years and up
SexAll
SponsorIDP Discovery Pharma S.L. Industry-sponsored
Locations11 sites (Santander, Cantabria and 10 other locations)
Trial IDNCT05908409 on ClinicalTrials.gov

What this trial studies

This is a Phase 1/2 open-label, multicenter clinical trial designed to evaluate the safety and efficacy of IDP-121 in patients with relapsed or refractory hematologic malignancies, including multiple myeloma and various types of lymphoma. The study consists of two phases: the first phase focuses on determining the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IDP-121, while the second phase assesses the overall response rate and other efficacy endpoints at the RP2D. Patients will be monitored for dose-limiting toxicities and overall survival outcomes throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory multiple myeloma or specific types of lymphoma who are ineligible for existing treatments.

Not a fit: Patients with early-stage hematologic malignancies or those who are not relapsed or refractory may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat blood cancers.

How similar studies have performed: Other studies have shown promising results with similar therapeutic approaches in hematologic malignancies, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥18 years
2. Performance status (ECOG) ≤ 2
3. Life expectancy ≥3 months
4. Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
5. Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
6. Patients diagnosed with chronic lymphocytic leukemia (CLL), B-cell lymphomas, and multiple myeloma (MM) who are ineligible to reveive the available treatments.
7. Adequate hematological or biochemical parameters as specified below

   1. Hemoglobin \> 8.0 g/dl (without transfusion support within 7 days)
   2. Platelets count \> 75 x109/L (without transfusional support within 7 days). In patients with bone marrow infiltration, the platelets count may be ≥50 x109/L.
   3. Absolute neutrophil count (ANC) \> 0.75 x109/L (without G-CSF support within 7 days)
   4. Aspartate transaminase (AST): \<2.5 x the upper limit range (in patients with no liver metastases or \<5 x ULN in patients with liver metastases)
   5. Alanine transaminase (ALT): \< 2.5 x the upper limit range (in patients with no liver metastases or \<5 x ULN in patients with liver metastases)
   6. Total bilirubin: \< 2 x the upper limit range.
   7. Calculated or measured creatinine clearance: \>30 mL/min (calculated from the Cockcroft-Gault formula).
8. Left ventricular ejection fraction \> 50% or above the Institutional Lower Limit of Normal (LLN), whichever is lower, determined by echocardiogram.

Exclusion Criteria:

1. Persistent clinically significant non-hematological toxicity related to previous treatments. The presence of alopecia and NCI-CTC grade \<2 symptomatic peripheral neuropathy is allowed.
2. Pregnant or lactating women; men and women of reproductive potential\* (as defined in the Appendix 2) who are not using effective contraceptive methods (combined hormonal contraception associated with inhibition of ovulation; progestogen-only hormonal contraception associated with inhibition of ovulation, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinenence).

   \*A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
3. History of any other neoplastic disease in the last five years (except basal cell carcinoma, skin epithelioma or carcinoma in situ of any site)
4. History of clinically significant hypotension.
5. History of clinically significant allergic or hyper-sensitivity reactions.
6. History or known clinically significant vascular disease or known high risk of vascular disease (as assessed by the treating physician) including (but not limited to):

   * Thromboembolism
   * Peripheral arterial disease
   * Vasculitis
7. Other relevant diseases or adverse clinical conditions:

   * Congestive heart failure or angina pectoris, myocardial infarction within 12 months before inclusion in the study.
   * Uncontrolled arterial hypertension or cardiac arrhythmias (i.e., requiring a change in medication within the last 3 months or hospital admission within the past 6 months).
   * History of significant neurological or psychiatric disorders
8. Clinically significant or active infection.
9. Significant non-neoplastic liver disease (e.g., cirrhosis, active chronic hepatitis)
10. The patient is known to be human immunodeficiency virus (HIV) positive, unless the patient is on antiviral therapy with HIV RNA levels \<50 copies/mL; Hepatitis B surface antigen-positive or active hepatitis C infection, unless treated with undetectable hepatitis B DNA or hepatitis C RNA levels; or active CMV infection (IgM positive).
11. Concomitant anti-tumor therapy within 14 days prior to Day 1 of Cycle 1.
12. Prior allogeneic transplantation in the last 3 months or currently active GVHD with immunosuppressive treatment
13. Limitation of the patient's ability to comply with the treatment or follow-up protocol.
14. If a COVID-19 vaccine is administered, it should be done \>72 hours prior to study treatment initiation or after the completion of the dose-limiting toxicity (DLT) period (if patient is participating in the dose-escalation phase").

Where this trial is running

Santander, Cantabria and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple MyelomaDiffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedDouble Hit LymphomaHigh Grade B-Cell Lymphoma, Not Otherwise SpecifiedChronic Lymphocytic LeukemiaTriple Hit Lymphoma
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.