Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors
NCT ID: NCT05007782
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
416 participants
INTERVENTIONAL
2021-08-18
2028-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part A - Denikitug Dose Escalation
Denikitug
Administered Intravenously
Part B - Mandatory Paired Tumor Biopsy
Denikitug
Administered Intravenously
Part C: Denikitug + Zimberelimab Dose Escalation
Denikitug
Administered Intravenously
Zimberelimab
Administered Intravenously
Part D: Denikitug + Zimberelimab Dose Expansion
Denikitug
Administered Intravenously
Zimberelimab
Administered Intravenously
Part E: Denikitug Monotherapy Dose Expansion
Denikitug
Administered Intravenously
Part F: Denikitug Monotherapy and In Combination With Zimberelimab In Select Dose and Schedule
Denikitug
Administered Intravenously
Zimberelimab
Administered Intravenously
Interventions
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Denikitug
Administered Intravenously
Zimberelimab
Administered Intravenously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of California San Diego
La Jolla, California, United States
Stanford Cancer Center
Palo Alto, California, United States
Smilow Cancer Center
New Haven, Connecticut, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States
MD Anderson Cancer Center
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
University of Wisconsin Clinical Sciences Center
Madison, Wisconsin, United States
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
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 Tzu Chi General Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan, , Taiwan
Countries
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Central Contacts
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Gilead Clinical Study Information Center
Role: CONTACT
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Related Links
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Gilead Clinical Trials Website
Other Identifiers
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2022-501684-40
Identifier Type: OTHER
Identifier Source: secondary_id
GS-US-570-6015
Identifier Type: -
Identifier Source: org_study_id