Recruiting nowPhase 1Randomised
What this trial is trying to do
CT-202 is a bispecific antibody designed to bind nectin-4 on cancer cells and engage T cells, directing the immune cells to attack the tumour. The trial is testing its safety, dose, drug effects in the body and tumour, and early signs of activity in people with recurrent colorectal cancer that has stopped responding to treatment.
The researchers hope that this targeted way of bringing T cells to cancer cells could offer an option when standard treatments are no longer controlling the disease. The main measures are whether doses can be given safely and tolerated, with preliminary measures of tumour response and how long disease control lasts—not whether it improves survival compared with another treatment.
Worth knowing: This is a first-in-human, early-phase, open-label study without a comparison group, and it is limited to cancers that express nectin-4 and cannot be removed surgically or have spread and resisted treatment.
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 | NCT07545122 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | randomised, open label |
| Taking part | 162 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Context Therapeutics Inc. |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug CT-202
What it is measuring
Phase 1a: Incidence of Dose Limiting Toxicities (DLTs)
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 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
This is a Phase 1a/1b, first time in human (FTIH), open-label, dose escalation and expansion study to evaluate the safety, tolerability, and preliminary efficacy of CT-202 (study drug), a humanized T cell engaging bispecific antibody targeting nectin-4, in participants with nectin-4 expressing recurrent, unresectable or metastatic refractory/resistant TNBC, CRC, or UC. Results of the study including PK, PD, efficacy, and safety will be used in the RP2D determination.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
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
- Participants with nectin-4-positive triple negative breast cancer, colorectal cancer, or urothelial cancer that have received standard therapies
- Participants with measurable disease per RECIST 1.1
- ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks
- Participants have adequate organ function.
Exclusion Criteria
- History of severe skin toxicity
- Uncontrolled significant active infection or any medical or other condition that in the opinion of the Investigator would preclude the participant's participation in the study.
- Concurrent participation in another investigational clinical trial.
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 4 sites. Listed in: Australia.
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 NCT07545122, registered by Context Therapeutics Inc. 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.