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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03881488 | Study of CTX-471 as a Monotherapy or in Combination With Pembrolizumab in Patients Post PD-1/PD-L1 Inhibitors in Metastatic or Locally Advanced Malignancies | PHASE1 | COMPLETED | 100 | — | — | May 17, 2019 | May 21, 2025 | Apr 17, 2026 | 10 | United States |
| Arm | Type | Description |
|---|---|---|
| Arm 1 Part 1 Dose Escalation | EXPERIMENTAL | Escalating doses of CTX-471 depending on cohort at enrollment |
| Arm 1 Part 2 Dose Expansion | EXPERIMENTAL | Two dose groups of CTX-471 (0.3 mg/kg and 0.6 mg/kg) |
| Arm 2 Part 1 Dose Escalation | EXPERIMENTAL | Escalating doses of CTX-471 in combination with pembrolizumab (KEYTRUDA® ) depending on cohort at enrollment |
| Arm 2 Part 2 Dose Expansion | EXPERIMENTAL | Two cohorts of CTX-471 (0.3 mg/kg and 0.6 mg/kg) in combination with pembrolizumab (KEYTRUDA® ) (400 mg) in three tumor type subgroups. Cohort 1 - Group 1A - NSCLC , Group 1B -SCLC and Group 1C - Melanoma. Cohort 2 Group 2A - NSCLC, Group 2B - SCLC and Group 2C -Melanoma. |
| Name | Type | Description |
|---|---|---|
| CTX-471 | DRUG | IV infusion every 2 weeks |
| Pembrolizumab (KEYTRUDA®) | DRUG | IV infusion every 6 weeks |
Inclusion Criteria: 1. Age 18 years or older 2. Histologically confirmed diagnosis: 1. Monotherapy Arm 1 ( Part 1 and 2): metastatic or locally advanced malignancies 2. Combination Arm 2 Par 1 Dose Escalation: metastatic or locally advanced non-small cell lung, small cell lung cancer, mesoth...