Recruiting
Phase 1

GS-1811 & Zimberelimab

Sponsor:

Gilead Sciences

Code:

NCT05007782

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Denikitug

Zimberelimab

Study Details

Brief summary:

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.

Conditions

Advanced Solid Tumor

Study ID

NCT05007782

Start date

Aug 18, 2021

Status verified date

Dec, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Disease:

  • Part A: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit.
  • Part B: Individuals with histologically or cytologically confirmed select indications who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit.
  • Part C: Individuals with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatments 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) 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 intolerant to, or have been ineligible 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 undergo combination therapy, have disease which is indicated for anti-PD-(L)1 mAb monotherapy.
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 for individuals in Parts A, B, and C, and 0 or 1 for individuals in Parts D, E, and F.
  • Adequate organ function.
  • Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception.
  • Tissue requirement:

  • Parts A, C, D, E and F: Must provide pre-treatment adequate tumor tissue sample prior to enrollment.
  • Part B and select participants in Parts C and F: Must have fresh pre-treatment and on-treatment biopsies for biomarker analysis.

Key Exclusion Criteria:

  • Concurrent anticancer treatment.
  • Any anti-cancer therapy, whether investigational or approved, within protocol specified time prior to initiation of study including: immunotherapy or biologic therapy (< 28 days), chemotherapy (< 21 days), targeted small molecule therapy (< 14 days), hormonal therapy or other adjunctive therapy (< 14 days) or radiotherapy (< 21 days).
  • Any prior CCR8 directed therapy.
  • Prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed.
  • Concurrent active malignancy other than nonmelanoma skin cancer, curatively resected carcinoma in situ, localized prostate cancer, or superficial bladder cancer after undergoing potentially curative therapy with no evidence of disease. Individuals with other previous malignancies are eligible if disease-free for > 2 years.
  • History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy.
  • History of autoimmune disease or active autoimmune disease requiring systemic treatment within 2 years.
  • History of pneumonitis, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis).
  • Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires IV antibiotics.
  • Active hepatitis B virus (HBV) and/or hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV).
  • Positive serum pregnancy test or breastfeeding female.
  • Live vaccines within 30 days prior to first dose.
  • Significant cardiovascular disease.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

416 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

Interventions

Denikitug

Administered Intravenously

Zimberelimab

Administered Intravenously

Primary outcome measure

  • Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Part A and C [ Time Frame: Day 1 Through Day 21 ]
  • Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [ Time Frame: First dose to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days ]
  • Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE v5.0 [ Time Frame: First dose to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Locations

University of California San Diego

Recruiting

La Jolla, California, United States, 92093

Stanford Cancer Center

Recruiting

Palo Alto, California, United States, 94305

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Tennessee Oncology, PLLC

Recruiting

Nashville, Tennessee, United States, 37203

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 39090

Sarah Cannon Research Institute at Mary Crowley

Recruiting

Dallas, Texas, United States, 75230

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

University of Wisconsin Clinical Sciences Center

Recruiting

Madison, Wisconsin, United States, 53705

University Health Network, Princess Margaret Cancer Centre

Recruiting

Toronto, Canada, M5G 2M9

More Information

Sponsor

Gilead Sciences

Last update posted

Dec 29, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2025-12-29.