A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Rec… (NCT06330064) | Clinical Trial Compass
RecruitingPhase 2
A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
United States520 participantsStarted 2024-04-10
Plain-language summary
This study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; and cutaneous melanoma.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Participants ages ≥18 years (follow local regulatory requirements if the legal age of consent for study participation is \>18 years).
✓. 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.
✓. Documentation of radiological disease progression on or after the previous standard-of-care regimen in the advanced/metastatic setting.
✓. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
✓. Pathologically or cytologically documented EC of any histological carcinoma subtype or endometrial carcinosarcoma, irrespective of microsatellite instability or mismatch repair status.
✓. Relapse or progression after a platinum-containing systemic treatment and an immune checkpoint inhibitor (ICI)-containing regimen (combined or sequential). Subjects with actionable target tumor mutation should have been previously treated with targeted therapy, with a maximum of 3 prior lines of therapy for endometrial carcinoma or carcinosarcoma. Neoadjuvant/adjuvant therapy may count as 1 line of therapy if the subject progressed within 6 months after completion of therapy.
What they're measuring
1
Objective Response Rate (ORR) as Assessed by Investigator
Timeframe: 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
2
Number of Participants Reporting Dose-limiting Toxicities in the HCC Cohort
Timeframe: Cycle 1 Day 1 to Cycle 1 Day 21
3
Number of Participants Reporting Treatment-emergent Adverse Events and Death in the HCC Cohort
Timeframe: From date of signing the informed consent form up to 47 days after the last dose of study drug , up to approximately 57 months
Trial details
NCT IDNCT06330064
SponsorDaiichi Sankyo
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2028-07-25
Contact for this trial
(US) Daiichi Sankyo Contact for Clinical Trial Information
✓. Pathologically or cytologically documented unresectable or metastatic squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx, excluding nasopharynx, nasal cavity and paranasal sinuses, and unknown primary.