RECRUITING

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

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Conditions

Advanced Solid Tumor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of 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

Quick Facts

Study Start:2021-08-18
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05007782

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Disease:
  2. * 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.
  3. * 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.
  4. * 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.
  5. * Part D: Individuals with pathologically confirmed select advanced solid tumors.
  6. * 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.
  7. * 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.
  8. * Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  9. * 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.
  10. * Adequate organ function.
  11. * Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use methods of contraception.
  12. * Tissue requirement:
  13. * Parts A, C, D, E and F: Must provide pre-treatment adequate tumor tissue sample prior to enrollment.
  14. * Part B and select participants in Parts C and F: Must have fresh pre-treatment and on-treatment biopsies for biomarker analysis.
  1. * Concurrent anticancer treatment.
  2. * 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).
  3. * Any prior CCR8 directed therapy.
  4. * Prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation. Exception: prior corneal transplant without requirement for systemic immunosuppressive agents is allowed.
  5. * 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.
  6. * History of intolerance, hypersensitivity, or treatment discontinuation due to severe immune-related adverse events (irAEs) on prior immunotherapy.
  7. * History of autoimmune disease or active autoimmune disease requiring systemic treatment within 2 years.
  8. * History of pneumonitis, interstitial lung disease, or severe radiation pneumonitis (excluding localized radiation pneumonitis).
  9. * Active and clinically relevant bacterial, fungal, or viral infection that is not controlled or requires IV antibiotics.
  10. * Active hepatitis B virus (HBV) and/or hepatitis C virus (HCV), and/or human immunodeficiency virus (HIV).
  11. * Positive serum pregnancy test or breastfeeding female.
  12. * Live vaccines within 30 days prior to first dose.
  13. * Significant cardiovascular disease.

Contacts and Locations

Study Contact

Gilead Clinical Study Information Center
CONTACT
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

University of California San Diego
La Jolla, California, 92093
United States
Stanford Cancer Center
Palo Alto, California, 94305
United States
Smilow Cancer Center
New Haven, Connecticut, 06510
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 39090
United States
Mary Crowley Cancer Research
Dallas, Texas, 75230
United States
MD Anderson Cancer Center
Houston, Texas, 77030
United States
NEXT Oncology
San Antonio, Texas, 78229
United States
University of Wisconsin Clinical Sciences Center
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: Gilead Sciences

  • Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-08-18
Study Completion Date2027-12

Study Record Updates

Study Start Date2021-08-18
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Solid Tumor