Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GV20-0251 · 1 trial · 7 indications
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...
GV20-0251 is an investigational monoclonal antibody being studied for the treatment of solid tumors in adults, including refractory cancer, endometrial carcinoma, squamous head and neck carcinoma, pMMR/MSS adenocarcinoma of the colon or rectum, cutaneous melanoma, and non-small cell lung cancer. It is currently in Phase 1 clinical development.
GV20-0251 is a monoclonal antibody, but its specific molecular target has not been disclosed. It is being studied as a monotherapy and in combination with pembrolizumab in patients with solid tumor malignancies.
GV20-0251 is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting a Phase 1 clinical trial of the drug in the United States.
GV20-0251 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing trial is recruiting participants with various solid tumor malignancies.
GV20-0251 is being evaluated in a Phase 1 trial with the identifier NCT05669430. The study is testing GV20-0251 as a monotherapy and in combination with pembrolizumab in participants with solid tumor malignancies, with an estimated enrollment of 365 participants.
No, GV20-0251 is not the same as pembrolizumab. GV20-0251 is a separate investigational monoclonal antibody being studied alone and in combination with pembrolizumab, which is an approved PD-1 inhibitor, in patients with solid tumors.