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Study of Denikitug for Advanced Solid Tumors

This study is testing Denikitug, a monoclonal antibody, alone or with Zimberelimab, in adults with advanced solid tumors. This is the first time these treatments are being given to people. The main goals are to understand the safety and side effects (adverse events) of these drugs, and to find the best dose to use in future studies. You may be able to join if you have advanced solid tumors and have already tried, couldn't tolerate, or weren't eligible for other treatments. The study aims to enroll 416 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It involves different parts, some testing Denikitug alone and others testing it with Zimberelimab. One part of the study will involve randomization, where participants are assigned to a treatment group by chance.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for adverse events and laboratory abnormalities from the first dose until the end of treatment (up to 12 months for Denikitug alone, and up to 24 months for Denikitug with Zimberelimab), plus an additional 90 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05007782

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

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
Gilead Sciences
~304 participants
Updated 2026-09-17 on ClinicalTrials.gov
What's tested:DenikitugZimberelimab

At a glance

Recruiting sites
0 of 25 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Part A and C
Measured over Day 1 Through Day 21
+2 more outcomes measured

Conditions

Advanced Solid Tumor

Explore related trials

Solid Neoplasm

NCT05007782

Where you'd take part

This study runs at 25 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Beth Israel Deaconess Medical Center

    Boston, Massachusettsno site contact published

  • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

    Taoyuan City, Taiwanno site contact published

  • Changhua Christian Hospital

    Changhua, Taiwanno site contact published

  • Chi Mei Hospital, Liouying

    Tainan, Taiwanno site contact published

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, Australiano site contact published

  • Clinica Universidad de Navarra

    Pamplona, Spainno site contact published

  • Hospital Universitari Vall d´Hebrón

    Barcelona, Spainno site contact published

  • Hospital Universitario 12 de Octubre

    Madrid, Spainno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Gilead Study Director · STUDY_DIRECTOR · Gilead Sciences

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Part A and CDay 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 5.0First 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 v5.0First dose to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days