Study of Ifinatamab Deruxtecan for Recurrent or Metastatic Solid Tumors
This study is testing a drug called ifinatamab deruxtecan (I-DXd) to see how well it works and if it's safe for people with recurrent (cancer that has come back) or metastatic (cancer that has spread) solid tumors. This includes many types of cancer like endometrial, head and neck, pancreatic, colorectal, and breast cancer. You might be able to join if you are 18 or older, have received at least one prior treatment for your cancer, and can provide a biopsy sample from a tumor that hasn't been treated with radiation. Researchers will be looking at how many people respond to the treatment (Objective Response Rate) and any side effects. The study is currently unclear on its recruitment status and plans to enroll 520 participants.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 520 participants and is divided into two stages, with a safety run-in for hepatocellular carcinoma (HCC) patients.
- What's involved
- You would receive ifinatamab deruxtecan intravenously. You would need to provide a biopsy tissue sample before treatment. Safety will be monitored from the time you sign the consent form up to 47 days after your last dose, and for up to approximately 57 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- You would be followed for safety for up to approximately 57 months from the time of the first dose, or up to 47 days after your last dose of the study drug.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
At a glance
Conditions
Where it's being run
120 sites across 54 statesWho to contact
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What this trial measures
- Objective Response Rate (ORR) as Assessed by InvestigatorFrom the time of the first dose of study drug until the date of documented disease progression, death, loss to follow-up, or withdrawal by the subject, whichever occurs first (up to approximately 60 months)
ORR is defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) as assessed by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Number of Participants Reporting Dose-limiting Toxicities (DLTs) in the HCC CohortCycle 1 Day 1 to Cycle 1 Day 21
A DLT is defined as any treatment-emergent adverse event (TEAE) not attributable to disease or disease-related processes that occurs during the DLT evaluation period (from C1D1 to the end of Cycle 1 in Safety Run-in) and is Grade 3 or above, according to NCI-CTCAE version 5.0, with the exceptions as noted in the protocol.
- Number of Participants Reporting TEAEs and Death in the HCC CohortFrom date of signing the informed consent form up to 47 days after the last dose of study drug, up to approximately 60 months
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment. TEAEs are defined as those AEs with start or worsening after the first dose date of I-DXd and up to 40 (+7) days after the last dose date of study drug.