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
Recruiting · NCT07545122 · Interventional (participants receive a specific treatment) · Lead sponsor: Context Therapeutics Inc.
View the official record on ClinicalTrials.gov →Interventions studied
CT-202
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
4 locations listed.
- Sydney Adventist Hospital - Wahroonga, New South Wales, Australia
- Tasman Oncology Research - Gold Coast, Queensland, Australia
- Calvary Mater Hospital Newcastle - Newcastle, Queensland, Australia
- Linear Clinical Research - Perth, Western Australia, Australia