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
Key facts
- Where
- Gold Coast, Heidelberg, Newcastle, Perth, Wahroonga, and Westmead, AustraliaSee the 6 sites
- Phase
- Phase 1
Where in Australia
- Tasman Oncology ResearchGold Coast, AustraliaTaking people
- Olivia Newton John Cancer CentreHeidelberg, AustraliaTaking people
- Calvary Mater Hospital NewcastleNewcastle, AustraliaTaking people
- Linear Clinical ResearchPerth, AustraliaTaking people
- Sydney Adventist HospitalWahroonga, AustraliaTaking people
- Crown Princess Mary Cancer Centre Westmead HospitalWestmead, AustraliaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Context Therapeutics Inc.
- Trial code
- NCT07545122
- Record updated
- 8 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Concurrent participation in another investigational clinical trial; 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.