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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06515613 | A Phase 1 Study of CTIM-76 in Patients With Recurring Ovarian Cancer and Other Advanced Solid Tumors | PHASE1 | RECRUITING | 156 | — | — | Jul 10, 2024 | Dec 31, 2028 | Jun 2, 2026 | 13 | United States |
Phase 1a will evaluate increasing doses of CTIM-76 based on the assessment of DLTs
ORR will be based on the best overall response rate as assessed by Investigators according to RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| CTIM-76 | EXPERIMENTAL | Phase 1a: Dose Escalation-each dose cohort will assess toxicity 28 days following the first dose of CTIM76; anticipate a total of 9 dose cohorts. Phase 1b: Dose Expansion - approximately 80 participants will be evaluated at a minimum of 2 dose levels and/or dosing schedules of CTIM-76 |
| Name | Type | Description |
|---|---|---|
| CTIM-76 | DRUG | CLDN6 bispecific Antibody administered weekly (Day 1, 8, 15 and 22) of a 28-day treatment cycle until disease progression. |
Inclusion Criteria: * Participants with CLDN6 positive platinum resistant/refractory ovarian, advanced testicular or advanced endometrial cancer. * Participants with measurable disease per RECIST 1.1. * ECOG 0, 1, or 2 and life expectancy of ≥ 12 weeks. * Participants with adequate organ function. ...