Opening soonPhase 3Randomised
| Registry number | NCT07722494 |
|---|---|
| Recruitment | Opening soon |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 550 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Innovent Biologics (Suzhou) Co. Ltd. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug IBI363 + bevacizumab
- Drug Investigator's choice of therapy
What it is measuring
Overall survival (OS)
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 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
This is an open-label, multicenter Phase 3 study to evaluate the safety and tolerability of IBI363 plus bevacizumab in patients with advanced colorectal cancer refractory or intolerant to standard-of-care therapy
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
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
Inclusion Criteria
1. Has signed the written Informed Consent Form and is capable of complying with the visit schedules and relevant procedures specified in the protocol.
2. Aged ≥ 18 years, with no restriction on gender.
3. Histologically or cytologically confirmed unresectable metastatic colorectal adenocarcinoma.
4. Has experienced treatment failure or intolerance to prior systemic standard therapies administered for metastatic disease, with failure or intolerance occurring on the most recent line of systemic therapy.
5. Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
6. Colorectal cancer characterized by proficient mismatch repair (pMMR), or microsatellite stable (MSS) status.
7. Confirmed adequate bone marrow and organ function at screening.
8. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
9. Expected survival duration ≥ 3 months.
10. Female subjects of childbearing potential, or male subjects whose partners are females of childbearing potential, agree to strictly use effective contraceptive measures throughout the treatment period and for 6 months after treatment completion. Lactating female subjects agree to completely refrain from breastfeeding throughout the treatment period and for 6 months after treatment completion.
Exclusion Criteria
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 2 sites. Listed in: China.
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?
The source
Registry record NCT07722494, registered by Innovent Biologics (Suzhou) Co. Ltd. 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.