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Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors

StatusActive, Not Recruiting
PhasePhase 1
Started2021-08-18
View on ClinicalTrials.gov ↗

Amendment history

2026-09-18
Enrollment closed, study ongoing
Final enrollment: 304 participants (planned 416)
2025-12-26
Study Status, Contacts/Locations v36
Study sites26 entries, revised
Sarah Cannon Research Institute at Mary Crowley Cancer Research
2025-07-22
Study Identification, Study Status, Study Design v35
Primary completion date2027-12→2028-12
Completion date2027-12→2028-12
Enrollment target376→416
Study title+12 characters
Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors
2024-12-18
Study Status, Study Description, Arms and Interventions, Outcome Measures v34
InterventionsGS-1811 (Drug), Zimberelimab (Drug)→Denikitug (Drug), Zimberelimab (Drug)
Secondary endpoints10 entries, revised
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for GS-1811Denikitug PK Parameter: Minimum Observed Concentration (Cmin) for GS-1811Denikitug PK Parameter: Time of Maximum Observed Concentration (Tmax) for GS-1811Denikitug PK Parameter: Area Under the Concentration-time Curve (AUC) for GS-1811Denikitug Percentage of Participants who Developed Antidrug Antibody (ADA) Against GS-1811Denikitug
2024-11-13
Study Status v33
Re-verified, no change to tracked fields
Show 32 earlier versions
2024-10-17
Study Status, Contacts/Locations v32
Study sitesdetails revised at 1 of 26 sites
2024-09-24
Study Status, Contacts/Locations v31
Study sitesdetails revised at 2 of 26 sites
2024-08-20
2 amendments v29-v30
2 re-verifications since 2024-07-30, no change to tracked fields
2024-07-01
Study Status, Contacts/Locations v28
Study sites23→26
2024-05-23
Study Status v27
Re-verified, no change to tracked fields
2024-04-23
Study Status, Contacts/Locations v26
Study sites22→23
2024-03-29
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v25
Primary completion date2026-06→2027-12
Completion date2027-02→2027-12
Enrollment target216→376
Study arms5→6
Eligibility criteria+461 characters
[...] ve received, been intolerant to, or been ineligible for all treatmenttreatments known to confer clinical benefit or whose disease is indicated for anti- programmed cell death protein 1 or programmed cell death ligand 1 (PD-([L]1)1 monoclonal antibody monotherapy. Part D: Individuals with p [...] ligible for all treatment known to confer clinical benefit. Part F: Individuals with pathologically-confirmed select advanced solid tumors. Participants must have received, have been intolerant to, or have been ineligible for all treatments known to confer clinical benefit; or, for participants who will under [...] [...]
Secondary endpoints10 entries, revised
Objective response rate (ORR) in Part D
Primary endpoints3 entries, revised
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Part A and C
Study sitesdetails revised at 1 of 22 sites
2024-02-22
Study Status v24
Re-verified, no change to tracked fields
2024-01-10
Study Status, Contacts/Locations v23
Study sites21→22
2023-12-19
Study Status, Contacts/Locations v22
Study sites20→21
2023-12-01
Study Status, Contacts/Locations v21
Study sites19→20
2023-11-03
Study Identification, Study Status, Contacts/Locations v20
Study sites16→19
2023-10-03
Study Status, Contacts/Locations v19
Study sites14→16
2023-08-23
Study Status, Contacts/Locations v18
Study sites13→14
2023-07-25
Study Status, Contacts/Locations v17
Study sites10→13
2023-06-26
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Eligibility, Contacts/Locations v16
Primary completion date2024-02→2026-06
Completion date2025-02→2027-02
Enrollment target158→216
Study sites9→10
Study arms4→5
Eligibility criteria+342 characters
Key Inclusion Criteria: Disease: Part A: Individuals with histologically or cytologically co [...] neligible for all treatment known to confer clinical benefit. Part B: Individuals with histologically or cytologically co [...] neligible for all treatment known to confer clinical benefit. Part C: Individuals with histologically or cytologically co [...] s indicated for anti-PD-(L)1 monoclonal antibody monotherapy. Part D: Individuals with pathologically confirmed select advanced solid tumors. Part E: Individuals with pathologically confirmed select advanced solid tumors. Participants must have received, have been i [...] [...]
Study title-59 characters
Study to Evaluate the Safety and Tolerability of GS-1811 asGiven MonotherapyAlone and in Combinationor With Zimberelimab in Adults With Advanced Solid Tumors
2023-05-24
2 amendments v14-v15
2 re-verifications since 2022-12-08, no change to tracked fields
2022-11-02
Study Status, Contacts/Locations v13
Study sites7→9
2022-10-03
2 amendments v11-v12
2 re-verifications since 2022-09-14, no change to tracked fields
2022-08-18
Study Identification, Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v10
Enrollment target62→158
Study sites4→7
Study arms3→4
InterventionsGS-1811 (Drug), Pembrolizumab (Drug)→GS-1811 (Drug), Zimberelimab (Drug)
Eligibility criteria+221 characters
Key Inclusion Criteria: Histologically or cytologically confirmed advanced solid tumorsDisease Part A: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to [...] t known to confer clinical benefit Part B: Individuals with histologically or cytologically confirmed select indications who have received, been intolerant to, or [...] nt known to confer clinical benefit Part C: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to [...] o confer clinical benefit or whose disease is indicated [...]
Secondary endpoints5 to 10 entries
Objective response rate (ORR) Disease control rate (DCR) Time to response (TTR) Duration of response (DOR) Progression-free survival (PFS)
Study description+50 characters
Part D allocation for 1 cohort will be randomized.
Study title-1 characters
Study to Evaluate the Safety and Tolerability of GS-1811 as Monotherapy and in Combination With PembrolizumabZimberelimab in Adults With Advanced Solid Tumors
2022-04-20
Study Status v9
Re-verified, no change to tracked fields
2022-03-11
Study Status, Contacts/Locations v8
Study sites3→4
2022-02-01
3 amendments v5-v7
3 re-verifications since 2022-01-04, no change to tracked fields
2021-11-30
Study Status, References v4
2021-11-01
Study Status, Contacts/Locations v3
Primary completion date2024-05→2024-02
Completion date2025-03→2025-02
Study sites2→3
2021-09-30
Study Status, Contacts/Locations v2
Study sites1→2
2021-08-31
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-08→confirmed 2021-08-18
Study sites0→1
2021-08-11
Original filing
Gilead Sciences
107 trials monitored
See 8 trials at risk
This is a first-in-human (FIH) study to evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of denikitug (also known as GS-1811) as monotherapy and in combination with zimberelimab in participants with advanced solid tumors. This study will be conducted in 6 parts (Parts A, B, and E: monotherapy, Parts C and D: combination therapy, and Part F for both monotherapy and combination therapy) in participants with advanced solid tumors who have received, been intolerant to, or been ineligible for all treatments known to confer clinical benefit or in participants with select solid tumors.
Trial Details
NCT Number NCT05007782
Lead Sponsor Gilead Sciences
Conditions Advanced Solid Tumor
Enrollment 304 participants
Start Date 2021-08-18
Primary Completion 2028-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-17