A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Rec… (NCT06330064) | Clinical Trial Compass
RecruitingPhase 1/2
A Study to Evaluate the Efficacy and Safety of Ifinatamab Deruxtecan (I-DXd) in Subjects With Recurrent or Metastatic Solid Tumors (IDeate-PanTumor02)
United States, Argentina, Australia680 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; cutaneous melanoma; and neuroendocrine carcinoma (NEC).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants must consent to provide a pretreatment tumor sample which has not been previously irradiated. Fresh biopsies are strongly preferred, however, if a fresh pretreatment biopsy is not feasible or the procedure is unsuccessful, an appropriate archival sample must be provided. The most recent archival sample obtained up to 5 years prior to consent is 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. For NEC participants for which the standard therapy does not exist OR for which the standard therapy is not appropriate by the investigator: presence of advanced/metastatic disease without previous regimen is acceptable.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1/Phase 2 trial that's still measuring safe dosing levels for certain groups like hepatocellular carcinoma patients, what does that mean for what's currently known about the risks and benefits for someone with my specific type of solid tumor?
2The trial is tracking 'dose-limiting toxicities' and treatment-related adverse events as primary outcomes — what kinds of side effects have been seen so far with ifinatamab deruxtecan, and how would those side effects be managed if I were to participate?
3My tumor is classified as recurrent or metastatic — does my particular cancer type and how many prior treatments I've had affect whether this trial might even be worth discussing as an option compared to standard treatments still available to me?
4This study is measuring objective response rate, which means tumor shrinkage — given that this is still an early-phase trial, how confident can we be in the results so far, and is there a chance I could be in a group where the dose or approach is still being adjusted?
5What would participation in this trial actually look like day-to-day — how often would I need to come in for treatment or monitoring, and is that realistic given my current health and life situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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 60 months)
2
Number of Participants Reporting Dose-limiting Toxicities (DLTs) in the HCC Cohort
Timeframe: Cycle 1 Day 1 to Cycle 1 Day 21
3
Number of Participants Reporting TEAEs 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 60 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
. 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). Participants 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.
. 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.
Exclusion criteria
. Prior treatment with orlotamab, enoblituzumab, or other B7-homologue 3 (B7-H3)-targeted agents, including I-DXd.
. Prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (e.g., T-DXd) due to treatment-related toxicities.
. Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms.
. Inadequate treatment washout period before enrollment as specified in the protocol.
. Any history of interstitial lung disease (ILD)/pneumonitis, current ILD, or suspicion of ILD.