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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05669430 | A Study of GV20-0251 Monotherapy and GV20-0251 in Combination With Pembrolizumab in Participants With Solid Tumor Malignancies | PHASE1 | RECRUITING | 365 | — | — | Mar 23, 2023 | Sep 5, 2027 | Feb 13, 2025 | 13 | United States |
ORR
| Arm | Type | Description |
|---|---|---|
| Part A - Dose Escalation in up to 7 dose levels | EXPERIMENTAL | A 3+3 dose escalation scheme will be used to evaluate the safety and tolerability of GV20-0251, and to establish the maximum tolerated dose (MTD) or the preliminary recommended Phase 2 dose (RP2D). |
| Part B - Multiple Expansion Cohorts in up to 4 tumor indications | EXPERIMENTAL | The Bayesian optimal design for Phase II (BOP2) will be utilized to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 at the preliminary RP2D in up to 4 expansion cohorts involving eligible participants. |
| Part C - GV20-0251 in Combination with Pembrolizumab Dose Escalation in 2-4 dose levels | EXPERIMENTAL | The Bayesian optimal interval (BOIN) design will be employed to evaluate the safety and tolerability of GV20-0251 in combination with pembrolizumab, and to determine the MTD or the preliminary RP2D of this combination in selected tumor indications. |
| Part D - GV20-0251 in Combination with Pembrolizumab Dose Expansion in up to 5 indications | EXPERIMENTAL | The BOP2 will be applied to further characterize the anti-tumor activities, safety, tolerability, pharmacokinetics, and pharmacodynamics of GV20-0251 in combination with pembrolizumab at the preliminary RP2D in up to 5 expansion cohorts involving eligible participants. |
| Name | Type | Description |
|---|---|---|
| GV20-0251 | BIOLOGICAL | Increasing doses of GV20-0251 administered by intravenous (IV) infusion once or twice every 3 weeks as monotherapy. |
| GV20-0251 and Pembrolizumab [KEYTRUDA®] | BIOLOGICAL | GV20-0251 administered by IV infusion at 10 mg/kg once every 3 weeks or at increasing doses up to the preliminary RP2D determined in Part A. 200 mg pembrolizumab administered by IV infusion once every 3 weeks. |
Inclusion Criteria: * Participants ≥18 years of age * Previously treated, histologically-confirmed advanced solid malignancy with progressive disease requiring therapy * Refractory or intolerant to standard therapy(ies) * Must have received, be not eligible or decline standard of care therapy * Par...