Recruiting nowPhase 2
What this trial is trying to do
The researchers are testing whether ifinatamab deruxtecan, an antibody–drug conjugate designed to carry a chemotherapy payload into B7-H3-bearing cancer cells, can shrink recurrent or metastatic colorectal and other solid tumours. They are also assessing its safety.
The idea is that directing the drug to tumour cells could produce responses in cancers that have returned or spread, where treatment options are limited. The main measure is the proportion of patients whose tumours respond, rather than how long they live or how long the cancer stays controlled.
Worth knowing: This is a non-randomised, multi-cancer Phase 2 study, so it has no comparison group and its main endpoint is tumour response rather than survival.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT06330064 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 2 |
| Design | not randomised, open label |
| Taking part | 680 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Daiichi Sankyo |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug Ifinatamab deruxtecan
What it is measuring
Objective Response Rate (ORR) as Assessed by Investigator
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 2. Tests whether the treatment works well enough to be worth a larger trial. Usually too small to prove it changes survival.
How the researchers describe it
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).
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- HER2 positive
- Metastatic
- Locally advanced
- Not yet treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Participants must meet all of the following criteria to be included in the study:
Common Inclusion Criteria for All Participants
1. 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.
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. 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.
5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Additional Inclusion Criteria for EC Participants
1.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 120 sites. Listed in: Argentina, Australia, Belgium, Brazil, Chile, France, Germany, Ireland, Italy, Japan, Mexico, Netherlands, Poland, Portugal, Spain, Taiwan, Turkey (Türkiye), United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
- This trial recruits across several cancer types rather than being designed around bowel cancer. Is there evidence it does anything in mine?
The source
Registry record NCT06330064, registered by Daiichi Sankyo on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.