Table of contents
- Overview of the IDP-121 trials
- Trial in relapsed or refractory blood cancers
- Trial in relapsed small cell lung cancer
- What the studies are trying to measure
- Who can take part
- How the trials are designed
Overview of the IDP-121 trials
Two authorised interventional studies are investigating IDP-121 in people with cancer.[1][2] Both studies are open-label, which means the treatment is known to the study team and the participants.[1][2] They are also multicenter studies, so they run at more than one site.[1][2]
Trial in relapsed or refractory blood cancers
The first study is a Phase 1/2 trial called CASSANDRA and includes people with relapsed or refractory hematologic malignancies.[1] The conditions listed are chronic lymphocytic leukemia (CLL), any type of B-cell lymphoma, and multiple myeloma (MM).[1] “Relapsed” means the cancer has returned, and “refractory” means it has not responded well to prior treatment.[1]
The study plans to include 62 patients and uses a dose-escalation part followed by an expansion part.[1] In the dose-escalation part, researchers aim to find the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) based on safety, pharmacokinetics, pharmacodynamics, and any cumulative toxicity after multiple cycles.[1] In simple terms, this means they are studying how much treatment can be given safely and which dose should be used later.[1]
The expansion part will look at the overall response rate (ORR) in patients with CLL, MM, or lymphoma treated at the RP2D.[1] ORR shows how many patients have their cancer shrink or improve during the study.[1]
Trial in relapsed small cell lung cancer
The second study is a Phase 1/2 trial called MYCrocytic and focuses on unresectable or metastatic small cell lung cancer (SCLC).[2] “Unresectable” means the cancer cannot be removed with surgery, and “metastatic” means it has spread to other parts of the body.[2]
This study plans to include 60 patients and tests IDP-121 together with chemotherapy.[2] The chemotherapy schedule named in the study is topotecan on days 1 to 5 every 3 weeks, or carboplatin on day 1 plus etoposide on days 1, 2, and 3 every 3 weeks.[2] The dose-escalation part aims to find the MTD and RP2D, and the RP2D is chosen using safety, pharmacokinetics, pharmacodynamics, and efficacy across dose groups.[2]
In the expansion part, the main endpoints are overall response rate (ORR) and disease control rate (DCR) using RECIST 1.1 criteria.[2] DCR means the share of patients whose cancer does not get worse, including those whose tumors shrink or stay stable.[2]
What the studies are trying to measure
Both trials are designed to learn the right dose of IDP-121 for later testing.[1][2] The key dose-related endpoints are MTD and RP2D, which help researchers balance safety and treatment use.[1][2]
The blood cancer study also measures ORR in CLL, MM, and lymphoma.[1] The lung cancer study measures ORR and DCR in SCLC.[2] These endpoints show early signs of whether the treatment may help the cancer respond or stay under control.[1][2]
Who can take part
In the CASSANDRA study, the target population is adults with chronic lymphocytic leukemia, B-cell lymphomas, or multiple myeloma that has relapsed or is refractory.[1] In the MYCrocytic study, the target population is adults with unresectable or metastatic small cell lung cancer.[2]
- CLL: a type of blood cancer that affects B cells, which are immune cells.[1]
- B-cell lymphoma: a cancer of lymphocytes, another type of immune cell.[1]
- Multiple myeloma: a cancer of plasma cells, which are a type of white blood cell.[1]
- Small cell lung cancer: an aggressive lung cancer type studied here when it is unresectable or metastatic.[2]
How the trials are designed
Both studies use a dose-escalation design first, then an expansion phase to learn more about activity at the selected dose.[1][2] This is common in early clinical research because it helps researchers move step by step from safety testing to a better look at benefit.[1][2]
The blood cancer study is listed as Phase 1/2, while the lung cancer study is also described as Phase 1/2, with the primary endpoints clearly split between dose-escalation and expansion parts.[1][2] The lung cancer study also uses RECIST 1.1, a standard system for measuring changes in tumor size on scans.[2]
