Actively Recruiting
Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors
Led by Gilead Sciences · Updated on 2025-12-29
416
Participants Needed
26
Research Sites
380 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study of Denikitug (GS-1811) Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or been ineligible for all treatments known to provide clinical benefit (varies by study part).
- Participants with measurable disease based on RECIST v1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 for Parts A, B, and C; ECOG 0 or 1 for Parts D, E, and F.
- Adequate organ function as determined by study assessments.
- Male and female participants of childbearing potential who engage in heterosexual intercourse must agree to use contraception.
- Must provide pre-treatment tumor tissue samples for biomarker analysis (requirements vary by study part).
You will not qualify if you...
- Receiving any concurrent anticancer treatment.
- Recent anticancer therapies within protocol-defined washout periods including immunotherapy or biologic therapy within 28 days, chemotherapy within 21 days, targeted small molecule therapy within 14 days, hormonal or adjunctive therapy within 14 days, or radiotherapy within 21 days prior to study start.
- Prior treatment with any CCR8-directed therapy.
- History of allogeneic tissue or solid organ transplantation (except corneal transplant without systemic immunosuppression).
- Active malignancies other than certain treated cancers or malignancies disease-free for over 2 years.
- History of severe immune-related adverse events leading to treatment discontinuation.
- History or active autoimmune diseases requiring systemic treatment within 2 years.
- History of lung diseases like pneumonitis or interstitial lung disease.
- Active uncontrolled infections requiring intravenous antibiotics.
- Active hepatitis B, hepatitis C, or HIV infection.
- Positive pregnancy test or currently breastfeeding.
- Receipt of live vaccines within 30 days before first dose.
- Significant cardiovascular disease.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
University of California San Diego
La Jolla, California, United States, 92093
Actively Recruiting
2
Stanford Cancer Center
Palo Alto, California, United States, 94305
Actively Recruiting
3
Smilow Cancer Center
New Haven, Connecticut, United States, 06510
Completed
4
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
Actively Recruiting
6
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 39090
Actively Recruiting
7
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States, 75230
Actively Recruiting
8
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
9
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
10
University of Wisconsin Clinical Sciences Center
Madison, Wisconsin, United States, 53705
Actively Recruiting
11
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Actively Recruiting
12
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Actively Recruiting
13
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
14
University Health Network, Princess Margaret Cancer Centre
Toronto, Canada, M5G 2M9
Actively Recruiting
15
Hospital Universitari Vall d´Hebrón
Barcelona, Spain, 08035
Actively Recruiting
16
MD Anderson Cancer Center
Madrid, Spain, 28033
Actively Recruiting
17
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Actively Recruiting
18
Hospital Universitario Quironsalud Madrid
Madrid, Spain, 28223
Actively Recruiting
19
Clinica Universidad de Navarra
Pamplona, Spain, 31008
Actively Recruiting
20
Changhua Christian Hospital
Changhua, Taiwan, 500
Actively Recruiting
21
Chi Mei Hospital, Liouying
Tainan, Taiwan, 73657
Actively Recruiting
22
National Taiwan University Cancer Center (NTUCC)
Taipei, Taiwan, 100229
Actively Recruiting
23
National Taiwan University Hospital
Taipei, Taiwan, 100
Actively Recruiting
24
Taipei Tzu Chi General Hospital
Taipei, Taiwan, 110
Withdrawn
25
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Actively Recruiting
26
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan City, Taiwan, 33308
Actively Recruiting
Research Team
G
Gilead Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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