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IDP-121

Clinical trials are investigating IDP-121 in people with relapsed or hard-to-treat blood cancers and in relapsed small cell lung cancer. These studies aim to find the safest dose and see how well IDP-121 works, alone or with chemotherapy, in specific patient groups.

Table of contents

Clinical trial overview

These two authorised studies are testing IDP-121 in people with serious cancers that have come back or not responded well to treatment.[1][2] Both trials are interventional, which means the researchers give a study treatment and then measure the results.[1][2]

Both studies use a dose-escalation design in the early part of the trial, which means the dose is increased step by step to find a safe dose.[1][2] They then move into an expansion part to learn more about how well the treatment works at the chosen dose.[1][2]

Blood cancer study: CASSANDRA

The first study is a phase 1/2 multicenter, open-label trial called CASSANDRA.[1] It is studying IDP-121 in patients with relapsed/refractory hematologic malignancies, which means blood cancers that have returned or did not respond well to treatment.[1]

This study includes people with chronic lymphocytic leukemia (CLL), any type of B-cell lymphomas, and multiple myeloma (MM).[1] The trial plans to enroll 62 patients and is currently authorised.[1]

In the phase 1 part, the study aims to find the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IDP-121.[1] In the phase 2 part, the study looks at the overall response rate (ORR) in CLL, MM, and lymphoma patients.[1]

Small cell lung cancer study: MYCrocytic

The second study is a phase 1/2 multicenter, two-arms, open-label trial called MYCrocytic.[2] It is testing IDP-121 in patients with unresectable/metastatic small cell lung cancer (SCLC), meaning lung cancer that cannot be removed by surgery or has spread to other parts of the body.[2]

This study plans to enroll 60 patients and is also authorised.[2] It studies IDP-121 together with chemotherapy, using topotecan, carboplatin, and etoposide in the dose-escalation part.[2]

In phase 1, the trial aims to find the MTD and RP2D for the combination treatment.[2] In the expansion phase, it measures overall response rate (ORR) and disease control rate (DCR) using standard tumor response rules called RECIST 1.1.[2]

Main endpoints and what they mean

The main goal in both studies is to understand safety first by looking for dose-limiting toxicities (DLTs) during the first treatment cycle.[1][2] A DLT is a side effect that is serious enough to affect whether the dose can be increased.[1][2]

Both trials use the MTD and RP2D to guide the next part of development.[1][2] The blood cancer study checks ORR as the main measure of activity in each disease group.[1] The lung cancer study checks ORR and DCR, which helps show whether the cancer shrinks or stays under control.[2]

The lung cancer study also considers pharmacokinetics (PK) and pharmacodynamics (PD) when choosing the RP2D.[2] PK means how the body handles the treatment, and PD means how the treatment affects the body.[2]

Who can participate

These studies are not for all cancer patients; they focus on specific groups.[1][2] The CASSANDRA trial is for patients with CLL, B-cell lymphomas, or multiple myeloma that has relapsed or is refractory.[1]

The MYCrocytic trial is for patients with relapsed, unresectable, or metastatic SCLC.[2] Because the trial data only list these disease groups, eligibility is limited to people with the conditions named in the study records.[1][2]

Study design and treatment plans

CASSANDRA is a multicenter, open-label study, so it is run at more than one site and everyone knows the treatment being given.[1] It studies IDP-121 as an intravenous infusion, which means the drug is given into a vein.[1]

MYCrocytic is also multicenter and open-label, and it has two arms in the dose-escalation part.[2] It studies IDP-121 as an intravenous infusion together with chemotherapy, and the expansion phase uses the dose selected from the earlier part of the trial.[2]

In both studies, the phase 1 part is about dose finding, and the phase 2 part is about learning more about treatment activity in the target cancers.[1][2]

Trial ID Phase Condition studied Status Enrollment
2024-519194-19-00 Phase 1/2 Relapsed/refractory chronic lymphocytic leukemia, B-cell lymphomas, multiple myeloma Authorised 62
2025-521902-17-00 Phase 1/2 Relapsed unresectable/metastatic small cell lung cancer Authorised 60

FAQ

  • What is being studied in the IDP-121 clinical trials? The trials are studying IDP-121 in relapsed or refractory hematologic malignancies, including chronic lymphocytic leukemia, B-cell lymphomas, and multiple myeloma, as well as in relapsed small cell lung cancer. One study tests IDP-121 alone, and another tests it with chemotherapy.
  • Who may take part in these trials? The blood cancer study includes patients with chronic lymphocytic leukemia, B-cell lymphomas, or multiple myeloma. The lung cancer study includes patients with unresectable or metastatic small cell lung cancer.
  • What phase are the IDP-121 trials in? Both studies are phase 1/2 trials. The phase 1 part looks at dose finding, and the phase 2 part looks more closely at how well treatment works.
  • What are the main goals of these trials? The main goals are to find the maximum tolerated dose and the recommended phase 2 dose. The studies also measure response to treatment, such as overall response rate and disease control rate.
  • Are these studies open to all cancer patients? No. These are focused studies with specific cancer types. Each trial has its own target group, so only people with the listed conditions may be considered.

Ongoing Clinical Trials on IDP-121

  • Study of IDP-121 for Patients with Relapsed or Refractory Multiple Myeloma, B-cell Lymphoma, or Chronic Lymphocytic Leukemia

    Recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

  • Study of IDP-121 with chemotherapy for patients with relapsed small cell lung cancer

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • Phase 1: The first part of a clinical trial. It mainly checks safety and helps find the right dose.
  • Phase 2: The part of a trial that looks more closely at whether the treatment may work in the target disease.
  • Open-label: A study where both the researchers and the participants know what treatment is being given.
  • Dose-escalation: A step-by-step approach where the dose is slowly increased in groups of patients to find a safe dose.
  • Maximum tolerated dose (MTD): The highest dose that most people can take without too many serious side effects.
  • Recommended phase 2 dose (RP2D): The dose chosen for later testing after looking at safety and how the body responds.
  • Dose-limiting toxicity (DLT): A side effect that is serious enough to limit how much of the study treatment can be given.
  • Pharmacokinetics (PK): How the body absorbs, moves, and removes a treatment.
  • Pharmacodynamics (PD): How a treatment affects the body.
  • Overall response rate (ORR): The percentage of patients whose cancer shrinks or disappears after treatment.
  • Disease control rate (DCR): The percentage of patients whose cancer does not get worse, including those with shrinkage or stable disease.
  • RECIST 1.1: A standard set of rules used to measure how tumors change on scans.

References

  1. https://clinicaltrials.gov/study/2024-519194-19-00
  2. https://clinicaltrials.gov/study/2025-521902-17-00