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

Last updated: December 18, 2024
Sponsor: Gilead Sciences
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Treatment

GS-1811

Zimberelimab

Denikitug

Clinical Study ID

NCT05007782
GS-US-570-6015
2022-501684-40-00
2022-501684-40
  • Ages > 18
  • All Genders

Study 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.

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

Total Participants: 376
Treatment Group(s): 3
Primary Treatment: GS-1811
Phase: 1
Study Start date:
August 18, 2021
Estimated Completion Date:
December 31, 2027

Study Description

Part D allocation for 1 cohort will be randomized.

Connect with a study center

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Monash Health

    Clayton South, Victoria 3169
    Australia

    Site Not Available

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • University Health Network, Princess Margaret Cancer Centre

    Toronto, M5G 2M9
    Canada

    Active - Recruiting

  • Hospital Universitari Vall d´Hebrón

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223
    Spain

    Active - Recruiting

  • MD Anderson Cancer Center

    Madrid, 28033
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Changhua Christian Hospital

    Changhua, 500
    Taiwan

    Active - Recruiting

  • Chi Mei Hospital, Liouying

    Tainan City, 73657
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • National Taiwan University Cancer Center (NTUCC)

    Taipei City, 100229
    Taiwan

    Active - Recruiting

  • Taipei Tzu Chi General Hospital

    Taipei City, 110
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

    Taoyuan City, 33308
    Taiwan

    Active - Recruiting

  • University of California San Diego

    La Jolla, California 92093
    United States

    Active - Recruiting

  • WCG IRB

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Stanford Cancer Center

    Palo Alto, California 94305
    United States

    Active - Recruiting

  • Smilow Cancer Center

    New Haven, Connecticut 06510
    United States

    Completed

  • Smilow Cancer Center, Yale University School of Medicine

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Tennessee Oncology, PLLC

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Mary Crowley Cancer Research

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • University of Texas Southwestern Medical Center

    Dallas, Texas 39090
    United States

    Active - Recruiting

  • MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

  • NEXT Oncology

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • University of Wisconsin Clinical Sciences Center

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

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