Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07545122 | 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 | PHASE1 | NOT YET_RECRUITING | 162 | — | — | Sep 1, 2026 | Jan 1, 2030 | Apr 22, 2026 | - | — |
Phase 1a will evaluate increasing doses of CT-202 based on the assessment of DLTs
ORR will be based on the overall response rate as assessed by Investigators according to RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Phase 1a | EXPERIMENTAL | Dose Escalation-Bayesian Optimal Interval (BOIN) Design with approximately 54 patients in dose escalation. |
| Phase 1b | EXPERIMENTAL | Phase 1b: Dose Expansion - participants will be evaluated in 4-6 cohorts at different doses and schedules of CT-202 |
| Name | Type | Description |
|---|---|---|
| CT-202 | DRUG | Nectin-4 bispecific |
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 adequa...