Phase
Condition
Neoplasms
Treatment
GS-1811
Zimberelimab
Denikitug
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Disease:
Part A: Individuals with histologically or cytologically confirmed advancedsolid tumors who have received, been intolerant to, or been ineligible for alltreatment known to confer clinical benefit.
Part B: Individuals with histologically or cytologically confirmed selectindications who have received, been intolerant to, or been ineligible for alltreatment known to confer clinical benefit.
Part C: Individuals with histologically or cytologically confirmed advancedsolid tumors who have received, been intolerant to, or been ineligible for alltreatments known to confer clinical benefit or whose disease is indicated foranti- 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 beenineligible 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 beenineligible for all treatments known to confer clinical benefit; or, forparticipants who will undergo combination therapy, have disease which isindicated 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 forindividuals 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 inheterosexual intercourse must agree to use methods of contraception.
Tissue requirement:
Parts A, C, D, E and F: Must provide pre-treatment adequate tumor tissue sampleprior to enrollment.
Part B and select participants in Parts C and F: Must have fresh pre-treatmentand on-treatment biopsies for biomarker analysis.
Exclusion
Key Exclusion Criteria:
Concurrent anticancer treatment.
Any anti-cancer therapy, whether investigational or approved, within protocolspecified time prior to initiation of study including: immunotherapy or biologictherapy (< 28 days), chemotherapy (< 21 days), targeted small molecule therapy (< 14days), 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 celltransplantation. Exception: prior corneal transplant without requirement forsystemic immunosuppressive agents is allowed.
Concurrent active malignancy other than nonmelanoma skin cancer, curatively resectedcarcinoma in situ, localized prostate cancer, or superficial bladder cancer afterundergoing potentially curative therapy with no evidence of disease. Individualswith other previous malignancies are eligible if disease-free for > 2 years.
History of intolerance, hypersensitivity, or treatment discontinuation due to severeimmune-related adverse events (irAEs) on prior immunotherapy.
History of autoimmune disease or active autoimmune disease requiring systemictreatment 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 notcontrolled or requires IV antibiotics.
Active hepatitis B virus (HBV) and/or hepatitis C virus (HCV), and/or humanimmunodeficiency 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.
Study Design
Study Description
Connect with a study center
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
AustraliaActive - Recruiting
Monash Medical Centre
Clayton, Victoria 3168
AustraliaActive - Recruiting
Monash Health
Clayton South, Victoria 3169
AustraliaSite Not Available
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
AustraliaActive - Recruiting
University Health Network, Princess Margaret Cancer Centre
Toronto, M5G 2M9
CanadaActive - Recruiting
Hospital Universitari Vall d´Hebrón
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario Quironsalud Madrid
Madrid, 28223
SpainActive - Recruiting
MD Anderson Cancer Center
Madrid, 28033
SpainActive - Recruiting
Clinica Universidad de Navarra
Pamplona, 31008
SpainActive - Recruiting
Changhua Christian Hospital
Changhua, 500
TaiwanActive - Recruiting
Chi Mei Hospital, Liouying
Tainan City, 73657
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, 100
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 11217
TaiwanActive - Recruiting
National Taiwan University Cancer Center (NTUCC)
Taipei City, 100229
TaiwanActive - Recruiting
Taipei Tzu Chi General Hospital
Taipei City, 110
TaiwanSite Not Available
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan City, 33308
TaiwanActive - Recruiting
University of California San Diego
La Jolla, California 92093
United StatesActive - Recruiting
WCG IRB
La Jolla, California 92093
United StatesActive - Recruiting
Stanford Cancer Center
Palo Alto, California 94305
United StatesActive - Recruiting
Smilow Cancer Center
New Haven, Connecticut 06510
United StatesCompleted
Smilow Cancer Center, Yale University School of Medicine
New Haven, Connecticut 06510
United StatesActive - Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesActive - Recruiting
Tennessee Oncology, PLLC
Nashville, Tennessee 37203
United StatesActive - Recruiting
Mary Crowley Cancer Research
Dallas, Texas 75230
United StatesActive - Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas 39090
United StatesActive - Recruiting
MD Anderson Cancer Center
Houston, Texas 77030
United StatesActive - Recruiting
NEXT Oncology
San Antonio, Texas 78229
United StatesActive - Recruiting
University of Wisconsin Clinical Sciences Center
Madison, Wisconsin 53705
United StatesActive - Recruiting
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