A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
A Phase 1B/2 Pan-Tumor, Open-Label Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
Sponsor: Daiichi Sankyo + Merck Sharp & Dohme LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Objective Response Rate (ORR) as Assessed by Investigator
Time frame: From 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 57 months
Number of Participants Reporting Dose-limiting Toxicities in the HCC Cohort
Time frame: Cycle 1 Day 1 to Cycle 1 Day 21
Number of Participants Reporting Treatment-emergent Adverse Events and Death in the HCC Cohort
Time frame: From date of signing the informed consent form up to 47 days after the last dose of study drug , up to approximately 57 months
Secondary Endpoints
Incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Duration of Response (DoR)
Progression-free Survival (PFS)
Eligibility Criteria
Participants must meet all of the following criteria to be included in the study: Common Inclusion Criteria for All Participants 1. Participant must have at least 1 lesion, not previously irradiated, amenable to core biopsy and must consent to provide a pretreatment biopsy tissue sample. An archival tumor tissue sample obtained within 6 months of consent and after progression during/after treatment with the participant's most recent cancer therapy regimen is also acceptable. 2. Participants ages ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \>18 years). 3. At least 1 measurable lesion on computed tomography (CT) or magnetic resonance imaging (MRI) according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), as assessed by the investigator. 4. Documentation of radiological disease progression on or after the previous standard-of-care regimen in the advanced/metastatic setting. 5. Has an Eastern Cooperativ…
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →