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Clinical Trials in the USA / NCT05007782
Active, not recruiting Phase 1

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

NCT05007782 · tracked via the Priya Life Science USA tracker
Sponsor
Gilead Sciences
Phase
Phase 1
Started
2021-08-18
Last updated
2026-09-17

Condition(s) studied

Advanced Solid Tumor

Investigational drug(s) / intervention(s)

Denikitug →Zimberelimab →

Denikitug: Administered Intravenously

Zimberelimab: Administered Intravenously

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (25)

FacilityCityRegionStatus
University of California San Diego La Jolla California
Stanford Cancer Center Palo Alto California
Smilow Cancer Center New Haven Connecticut
Beth Israel Deaconess Medical Center Boston Massachusetts
Tennessee Oncology, PLLC Nashville Tennessee
University of Texas Southwestern Medical Center Dallas Texas
Sarah Cannon Research Institute at Mary Crowley Dallas Texas
MD Anderson Cancer Center Houston Texas
NEXT Oncology San Antonio Texas
University of Wisconsin Clinical Sciences Center Madison Wisconsin
Chris O'Brien Lifehouse Camperdown New South Wales
Monash Medical Centre Clayton Victoria
Peter MacCallum Cancer Centre Melbourne Victoria
University Health Network, Princess Margaret Cancer Centre Toronto Canada
Hospital Universitari Vall d´Hebrón Barcelona Spain
MD Anderson Cancer Center Madrid Spain
Hospital Universitario 12 de Octubre Madrid Spain
Hospital Universitario Quironsalud Madrid Madrid Spain
Clinica Universidad de Navarra Pamplona Spain
Changhua Christian Hospital Changhua Taiwan
Chi Mei Hospital, Liouying Tainan Taiwan
National Taiwan University Cancer Center (NTUCC) Taipei Taiwan
National Taiwan University Hospital Taipei Taiwan
Taipei Veterans General Hospital Taipei Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital Taoyuan City Taiwan

More Gilead Sciences trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05007782 on ClinicalTrials.gov ↗ ← All trials in the USA