In short
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.
Key points
- IDP-121 is being studied in two authorised phase 1/2 clinical trials. One trial looks at relapsed or refractory blood cancers, including chronic lymphocytic leukemia, B-cell lymphomas, and multiple myeloma. The other trial studies relapsed small cell lung cancer and tests IDP-121 with chemotherapy. Both studies aim to find the maximum tolerated dose and the recommended phase 2 dose. They also measure how well treatment works using outcomes like overall response rate and disease control rate.
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. Both trials are interventional, which means the researchers give a study treatment and then measure the results.
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. They then move into an expansion part to learn more about how well the treatment works at the chosen dose.
Blood cancer study: CASSANDRA
The first study is a phase 1/2 multicenter, open-label trial called CASSANDRA. 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.
This study includes people with chronic lymphocytic leukemia (CLL), any type of B-cell lymphomas, and multiple myeloma (MM). The trial plans to enroll 62 patients and is currently authorised.
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. In the phase 2 part, the study looks at the overall response rate (ORR) in CLL, MM, and lymphoma patients.
Small cell lung cancer study: MYCrocytic
The second study is a phase 1/2 multicenter, two-arms, open-label trial called MYCrocytic. 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.
This study plans to enroll 60 patients and is also authorised. It studies IDP-121 together with chemotherapy, using topotecan, carboplatin, and etoposide in the dose-escalation part.
In phase 1, the trial aims to find the MTD and RP2D for the combination treatment. In the expansion phase, it measures overall response rate (ORR) and disease control rate (DCR) using standard tumor response rules called RECIST 1.1.
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. A DLT is a side effect that is serious enough to affect whether the dose can be increased.
Both trials use the MTD and RP2D to guide the next part of development. The blood cancer study checks ORR as the main measure of activity in each disease group. The lung cancer study checks ORR and DCR, which helps show whether the cancer shrinks or stays under control.
The lung cancer study also considers pharmacokinetics (PK) and pharmacodynamics (PD) when choosing the RP2D. PK means how the body handles the treatment, and PD means how the treatment affects the body.
Who can participate
These studies are not for all cancer patients; they focus on specific groups. The CASSANDRA trial is for patients with CLL, B-cell lymphomas, or multiple myeloma that has relapsed or is refractory.
The MYCrocytic trial is for patients with relapsed, unresectable, or metastatic SCLC. Because the trial data only list these disease groups, eligibility is limited to people with the conditions named in the study records.
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. It studies IDP-121 as an intravenous infusion, which means the drug is given into a vein.
MYCrocytic is also multicenter and open-label, and it has two arms in the dose-escalation part. 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.
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.