Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Denikitug · 3 trials · 6 indications
ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR) as assessed by the investigator according to RECIST Version 1.1.
| Arm | Type | Description |
|---|---|---|
| Part 1: Arm A: DEN (Dose A) and NIVO | EXPERIMENTAL | Participants will receive DEN Dose A as an IV infusion in combination with NIVO as an IV infusion. |
| Part 1: Arm B: DEN (Dose B) and NIVO | EXPERIMENTAL | Participants will receive DEN Dose B as an IV infusion in combination with NIVO as an IV infusion. |
| Part 1: Arm C: DEN (Dose B) | EXPERIMENTAL | Participants will receive DEN Dose B as an IV infusion. |
| Part 2: Arm D: Safety Run-in (SRI) Cohort | EXPERIMENTAL | Participants will receive DEN in combination with ramucirumab (RAM) and paclitaxel (PAC). If dose for DEN is deemed safe during the SRI Cohort, the study will move forward into the Expansion Period. |
| Part 2: Arm D: Expansion Cohort | EXPERIMENTAL | If DEN dose is deemed safe in Arm D: SRI Cohort, participants will receive DEN at recommended dose as an IV infusion in combination with RAM and PAC. |
| DEN monotherapy (Arm A) | EXPERIMENTAL | Participants will receive DEN via intravenous (IV) infusion. |
| DEN in combination with NIVO (Arm B) | EXPERIMENTAL | Participants will receive DEN as an IV infusion in combination with NIVO as an IV infusion. |
| DEN in combination with Trifluridine-Tipiracil (FTD-TPI) and BVZ (Arm C) | EXPERIMENTAL | Participants will receive DEN as an IV infusion in combination with BVZ as an IV infusion and FTD-TPI administered orally. Includes a Safety Run-in cohort (non-randomized cohort) prior to randomization. |
| Standard of care (SOC) alone: BVZ and FTD-TPI (Arm D) | ACTIVE_COMPARATOR | Participants will receive BVZ as an IV infusion and FTD-TPI administered orally as SOC. |
| Part A - Denikitug Dose Escalation | EXPERIMENTAL | - |
| Part B - Mandatory Paired Tumor Biopsy | EXPERIMENTAL | - |
| Part C: Denikitug + Zimberelimab Dose Escalation | EXPERIMENTAL | - |
| Part D: Denikitug + Zimberelimab Dose Expansion | EXPERIMENTAL | - |
| Part E: Denikitug Monotherapy Dose Expansion | EXPERIMENTAL | - |
| Part F: Denikitug Monotherapy and In Combination With Zimberelimab In Select Dose and Schedule | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Denikitug | DRUG | Administered Intravenously |
| Nivolumab | DRUG | Administered Intravenously |
| Ramucirumab | DRUG | Administered Intravenously |
| Paclitaxel | DRUG | Administered Intravenously |
| Bevacizumab | DRUG | Administered Intravenously |
| Trifluridine-Tipiracil | DRUG | Administered orally |
| Zimberelimab | DRUG | Administered Intravenously |
Key Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of locally advanced, unresectable, or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC). * Human epidermal growth factor receptor 2 (HER2)-negative status, as determined by local asse...
Denikitug is an investigational small molecule being studied for advanced microsatellite stable colorectal cancer, HER2-negative advanced solid tumors, and other advanced solid tumors. It is being evaluated alone or in combination with other therapies in clinical trials for these oncology indications.
Denikitug is a small molecule oncology drug. Its specific molecular target has not been disclosed in the available information, so its mechanism of action is not detailed here.
Denikitug is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol GILD.
Denikitug is in Phase 2 clinical development. It is being studied in a Phase 2 trial for advanced microsatellite stable colorectal cancer and in another Phase 2 trial for HER2-negative gastric, gastroesophageal junction, and esophageal adenocarcinomas. It is also in a Phase 1 trial for advanced solid tumors.
Denikitug is being studied in three recruiting trials. NCT05007782 is a Phase 1 study of Denikitug alone or with zimberelimab in advanced solid tumors. NCT07527858 is a Phase 2 study with nivolumab or chemotherapy in advanced colorectal cancer. NCT07546812 is a Phase 2 study with nivolumab or chemotherapy in gastric, GEJ, and esophageal adenocarcinomas.
Yes, Denikitug is also known as GS-1811. Clinical trial records refer to the drug as Denikitug (GS-1811), indicating that both names refer to the same investigational agent.