Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as GS-1811, DEN
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 being studied in adults with advanced cancers, including microsatellite stable colorectal cancer, HER2-negative gastric, gastroesophageal junction and esophageal adenocarcinomas, and advanced solid tumors. It is an investigational therapy and has not been approved for any indication. Clinical testing is ongoing in Phase 2 and earlier-stage studies.
Denikitug is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. The company is running the clinical program, which includes studies of Denikitug given alone or in combination with nivolumab, zimberelimab, or chemotherapy in adults with advanced solid tumors and gastrointestinal cancers.
Denikitug is in Phase 2 clinical development. Two Phase 2 trials are currently recruiting, one in advanced colorectal cancer and one in HER2-negative gastric, gastroesophageal junction and esophageal adenocarcinomas. An earlier Phase 1 study in advanced solid tumors is active but no longer recruiting participants.
Denikitug is being evaluated in three registered studies. NCT07527858 is a recruiting Phase 2 trial in advanced microsatellite stable colorectal cancer with 170 planned participants. NCT07546812 is a recruiting Phase 2 trial in HER2-negative gastric, gastroesophageal junction and esophageal adenocarcinomas with 120 planned participants. NCT05007782 is a Phase 1 advanced solid tumor study with 304 participants.
Yes, Denikitug is also known as GS-1811. The two names refer to the same investigational agent, and Gilead Sciences uses GS-1811 in the titles of its registered clinical trials. Searches for either name lead to the same development program in advanced solid tumors and gastrointestinal cancers.
The Denikitug trials enroll adults across multiple countries. The Phase 2 colorectal cancer study operates in the United States, Australia, South Korea and Spain, while the Phase 2 gastroesophageal study runs in the United States, Australia, France, South Korea and Spain. The Phase 1 solid tumor study includes sites in the United States, Australia, Canada, Spain and Taiwan.