OVERVIEW
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
PROTOCOL 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. 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.
View moreParticipation requirements
Age
18 years +
Sex
All
Healthy Volunteers
No
Age
18 years +
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
Advanced Solid Tumor
Gender
N/A
Date
August 2021 - December 2028
Study Type
Interventional
Study Phase
Phase 1
Product
Denikitug, Zimberelimab
Eligibility information
Inclusion criteria
- 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 criteria
- 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.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Locations
Locations (26)
University of California San Diego
La Jolla, California, United States, 92093
Stanford Cancer Center
Palo Alto, California, United States, 94305
Smilow Cancer Center
New Haven, Connecticut, United States, 06510
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37203
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 39090
Sarah Cannon Research Institute at Mary Crowley
Dallas, Texas, United States, 75230
University of Wisconsin Clinical Sciences Center
Madison, Wisconsin, United States, 53705
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
University Health Network, Princess Margaret Cancer Centre
Toronto, Canada, M5G 2M9
National Taiwan University Cancer Center (NTUCC)
Taipei, Taiwan, 100229
Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital
Taoyuan City, Taiwan, 33308
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