NCT07545122RecruitingPhase 1
A Phase 1a/1b, First-Time-in-Human Study of CT-202, a Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, Urothelial Cancers
A Phase 1a/1b, First Time in Human Study of CT-202, A Nectin-4 Directed Bispecific Antibody, in Participants With Recurring Triple Negative Breast, Colorectal, and Urothelial Cancers
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 162 (estimated)
- First submitted
- 16 Apr 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Jan 2030
- Lead sponsor
- Context Therapeutics Inc.
- NCT number
- NCT07545122
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 162
- From 1 Sept 2026 to the primary completion date, 31 Jan 2030
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in another investigational clinical trial.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tasman Oncology Research Coordinator of this site? Confirm its status | Gold Coast | Australia | Recruiting |
| Olivia Newton John Cancer Centre Coordinator of this site? Confirm its status | Heidelberg | Australia | Recruiting |
| Calvary Mater Hospital Newcastle Coordinator of this site? Confirm its status | Newcastle | Australia | Recruiting |
| Linear Clinical Research Coordinator of this site? Confirm its status | Perth | Australia | Recruiting |
| Sydney Adventist Hospital Coordinator of this site? Confirm its status | Wahroonga | Australia | Recruiting |
| Crown Princess Mary Cancer Centre Westmead Hospital Coordinator of this site? Confirm its status | Westmead | Australia | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.