First-in-human test of CT-202, a nectin-4 directed bispecific antibody for recurrent TNBC, colorectal and urothelial cancers
Official title: 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
Run by Context Therapeutics Inc. · NCT07545122 · Data updated 2026-11-12
This phase 1a/1b study tests CT-202 to see if it is safe and tolerable and to get early signals of activity in patients with nectin-4–expressing recurrent or metastatic TNBC, colorectal cancer, or urothelial cancer who have exhausted standard therapies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 162 (estimated) |
| Sponsor | Context Therapeutics Inc. Industry-sponsored |
| Locations | 6 sites (Wahroonga, New South Wales and 5 other locations) |
| Status | Recruiting |
| Started | September 2026 |
| Main results expected | January 2030 |
| Study ends | January 2030 |
| Registry record updated | October 8, 2026 |
| Trial ID | NCT07545122 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with nectin-4–positive recurrent or metastatic TNBC, colorectal cancer, or urothelial cancer who have received standard therapies and have measurable disease (RECIST 1.1).
✕Probably not a fit
Patients with severe skin toxicity history, uncontrolled infections, or contraindications to study procedures may not benefit from CT-202.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
CT-202 is a humanized bispecific antibody that engages T cells to target nectin-4 on tumor cells. The study uses a dose-escalation (Phase 1a) with a Bayesian design and stepwise priming dosing, followed by dose expansion (Phase 1b) to explore multiple dose levels and schedules across TNBC, colorectal, and urothelial cancers. Primary goals are safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy to determine a recommended phase 2 dose. Participants may remain on treatment until disease progression, unacceptable toxicity, or withdrawal. The trial is open-label and conducted at sites in Australia across three cancer centers.
Why it matters
Potential benefit: If CT-202 shows acceptable safety and early signs of tumor control, participants may benefit from potential tumor shrinkage or slowed disease progression, contributing to dose optimization for future studies.
How similar studies have gone: Other nectin-4–targeting or T cell–engaging bispecific antibodies have shown activity in solid tumors, supporting the rationale for this approach, though this exact agent is in early development.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia Recruiting -
Crown Princess Mary Cancer Centre Westmead Hospital
Westmead, New South Wales, Australia Recruiting -
Tasman Oncology Research
Gold Coast, Queensland, Australia Recruiting -
Calvary Mater Hospital Newcastle
Newcastle, Queensland, Australia Recruiting -
Olivia Newton John Cancer Centre
Heidelberg, Victoria, Australia Recruiting -
Linear Clinical Research
Perth, Western Australia, Australia Recruiting
Study contacts
- Study coordinator: Context Clinical Development
- Email: Cntx-ct202-101@contexttherapeutics.com
- Phone: 267.225.7416
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.