Advanced Solid TumorPhase 1NCT05007782
Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors
A Phase 1 study testing Denikitug and Zimberelimab in people with Advanced Solid Tumor, run by Gilead Sciences at 25 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Denikitug and Zimberelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 25 sitesin 5 countries
- Study dates
- 18 Aug 2021to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
25 sites in 5 countries.
25 sites in 5 countries
United States10 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Texas Southwestern Medical Center
Dallas, Texas, 39090
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, 75230
MD Anderson Cancer Center
Houston, Texas, 77030
University of California San Diego
La Jolla, California, 92093
University of Wisconsin Clinical Sciences Center
Madison, Wisconsin, 53705
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Smilow Cancer Center
New Haven, Connecticut, 06510
Stanford Cancer Center
Palo Alto, California, 94305
NEXT Oncology
San Antonio, Texas, 78229
Taiwan6 sites
Changhua Christian Hospital
Changhua, 500
Chi Mei Hospital, Liouying
Tainan, 73657
National Taiwan University Cancer Center (NTUCC)
Taipei, 100229
National Taiwan University Hospital
Taipei, 100
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan City, 33308
Spain5 sites
Hospital Universitari Vall d´Hebrón
Barcelona, 08035
MD Anderson Cancer Center
Madrid, 28033
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario Quironsalud Madrid
Madrid, 28223
Clinica Universidad de Navarra
Pamplona, 31008
Australia3 sites
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Monash Medical Centre
Clayton, Victoria, 3168
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Canada1 site
University Health Network, Princess Margaret Cancer Centre
Toronto, M5G 2M9
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Denikitug (GS-1811), an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors
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.
Read the detailed description
Part D allocation for 1 cohort will be randomized.
- Conditions
- Advanced Solid Tumor
- Being tested
- Denikitug, Zimberelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenikitugDrug
Also called GS-1811
Administered Intravenously
ZimberelimabDrug
Administered Intravenously
| Study group | Role | What they receive |
|---|---|---|
| Part A - Denikitug Dose Escalation | Experimental | Not described Receives: Drug: Denikitug |
| Part B - Mandatory Paired Tumor Biopsy | Experimental | Not described Receives: Drug: Denikitug |
| Part C: Denikitug + Zimberelimab Dose Escalation | Experimental | Not described Receives: Drug: Denikitug; Drug: Zimberelimab |
| Part D: Denikitug + Zimberelimab Dose Expansion | Experimental | Not described Receives: Drug: Denikitug; Drug: Zimberelimab |
| Part E: Denikitug Monotherapy Dose Expansion | Experimental | Not described Receives: Drug: Denikitug |
| Part F: Denikitug Monotherapy and In Combination With Zimberelimab In Select Dose and Schedule | Experimental | Not described Receives: Drug: Denikitug; Drug: Zimberelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Part A and C
Measured: 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
Measured: 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
Measured: First dose to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Secondary outcomes (10)
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for Denikitug
Measured: Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
PK Parameter: Minimum Observed Concentration (Cmin) for Denikitug
Measured: Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
PK Parameter: Time of Maximum Observed Concentration (Tmax) for Denikitug
Measured: Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
PK Parameter: Area Under the Concentration-time Curve (AUC) for Denikitug
Measured: Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Percentage of Participants who Developed Antidrug Antibody (ADA) Against Denikitug
Measured: Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Objective response rate (ORR) in Part D
Objective response rate is defined as the proportion of participants who achieve complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Measured: Day 1 Up to End of Treatment (24 months)
Disease control rate (DCR)
Disease control rate is defined as the proportion of participants who achieve CR, PR, or stable disease (SD) as assessed by RECIST Version 1.1
Measured: Day 1 Up to End of Treatment (24 months)
Time to response (TTR)
Time to response is defined as the time from the first dose of Denikitug in combination with Zimberelimab to the first documentation of CR or PR that is subsequently confirmed
Measured: Day 1 Up to End of Treatment (24 months)
Duration of response (DOR)
Duration of response is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive progressive disease (PD) or death from any cause, if applicable.
Measured: Day 1 Up to End of Treatment (24 months)
Progression-free survival (PFS)
Progression-free survival is defined as the time from the first dose of Denikitug in combination with Zimberelimab to the earlier of the first documentation of definitive PD or death from any cause
Measured: Day 1 Up to End of Treatment (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start18 Aug 2021
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007782
- Sponsor's protocol ID
- GS-US-570-6015
- Other IDs
- 2022-501684-40
- Status last verified
- Sep 2026
- First submitted
- 11 Aug 2021
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Denikitug (GS-1811), an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05007782
- Acronym / sponsor ID
- GS-US-570-6015
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Part D allocation for 1 cohort will be randomized.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A - Denikitug Dose Escalation | Experimental | Drug: Denikitug |
| Part B - Mandatory Paired Tumor Biopsy | Experimental | Drug: Denikitug |
| Part C: Denikitug + Zimberelimab Dose Escalation | Experimental | Drug: Denikitug, Drug: Zimberelimab |
| Part D: Denikitug + Zimberelimab Dose Expansion | Experimental | Drug: Denikitug, Drug: Zimberelimab |
| Part E: Denikitug Monotherapy Dose Expansion | Experimental | Drug: Denikitug |
| Part F: Denikitug Monotherapy and In Combination With Zimberelimab In Select Dose and Schedule | Experimental | Drug: Denikitug, Drug: Zimberelimab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Disease:
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DenikitugAlso: GS-1811Administered Intravenously | Drug | Part A - Denikitug Dose Escalation, Part B - Mandatory Paired Tumor Biopsy, Part C: Denikitug + Zimberelimab Dose Escalation, Part D: Denikitug + Zimberelimab Dose Expansion, Part E: Denikitug Monotherapy Dose Expansion, Part F: Denikitug Monotherapy and In Combination With Zimberelimab In Select Dose and Schedule |
| ZimberelimabAdministered Intravenously | Drug | Part C: Denikitug + Zimberelimab Dose Escalation, Part D: Denikitug + Zimberelimab Dose Expansion, Part F: Denikitug Monotherapy and In Combination With Zimberelimab In Select Dose and Schedule |
Primary outcome
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
10 secondary outcomes
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for Denikitug
Time frame: Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
PK Parameter: Minimum Observed Concentration (Cmin) for Denikitug
Time frame: Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
PK Parameter: Time of Maximum Observed Concentration (Tmax) for Denikitug
Time frame: Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
PK Parameter: Area Under the Concentration-time Curve (AUC) for Denikitug
Time frame: Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Percentage of Participants who Developed Antidrug Antibody (ADA) Against Denikitug
Time frame: Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Objective response rate (ORR) in Part D
Time frame: Day 1 Up to End of Treatment (24 months)
Disease control rate (DCR)
Time frame: Day 1 Up to End of Treatment (24 months)
Time to response (TTR)
Time frame: Day 1 Up to End of Treatment (24 months)
Duration of response (DOR)
Time frame: Day 1 Up to End of Treatment (24 months)
Progression-free survival (PFS)
Time frame: Day 1 Up to End of Treatment (24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilead Study Director study director
Gilead Sciences
25 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Denikitug and Zimberelimab in people with Advanced Solid Tumor, run by Gilead Sciences at 25 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Taiwan, Spain, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Part A and C (time frame: Day 1 Through Day 21). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.