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STATUS Recruiting

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

LAST UPDATED

December 20 2024

Clinicaltrials.gov ID

NCT05007782

CTSID

2022-501684-40

OVERVIEW

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

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.

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Participation Requirements

Calendar

Age

18 Years +

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Advanced Solid Tumor

Gender

N/A

Date

August 2021 - December 2027

Study Type

INTERVENTIONAL

Study Phase

PHASE1

Product

Denikitug, Zimberelimab

Eligibility Information

Inclusion

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.
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Exclusion

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.
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Locations

Locations (26)
Recruiting

University of California San Diego

La Jolla, California, United States, 92093

Recruiting

Stanford Cancer Center

Palo Alto, California, United States, 94305

Study Complete

Smilow Cancer Center

New Haven, Connecticut, United States, 06510

Recruiting

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Recruiting

Tennessee Oncology, PLLC

Nashville, Tennessee, United States, 37203

Recruiting

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 39090

Recruiting

Mary Crowley Cancer Research

Dallas, Texas, United States, 75230

Recruiting

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Recruiting

NEXT Oncology

San Antonio, Texas, United States, 78229

Recruiting

University of Wisconsin Clinical Sciences Center

Madison, Wisconsin, United States, 53705

Recruiting

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia, 2050

Recruiting

Monash Medical Centre

Clayton, Victoria, Australia, 3168

Recruiting

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia, 3000

Recruiting

University Health Network, Princess Margaret Cancer Centre

Toronto, Canada, M5G 2M9

Recruiting

Hospital Universitari Vall d´Hebrón

Barcelona, Spain, 08035

Recruiting

MD Anderson Cancer Center

Madrid, Spain, 28033

Recruiting

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Recruiting

Hospital Universitario Quironsalud Madrid

Madrid, Spain, 28223

Recruiting

Clinica Universidad de Navarra

Pamplona, Spain, 31008

Recruiting

Changhua Christian Hospital

Changhua, Taiwan, 500

Recruiting

Chi Mei Hospital, Liouying

Tainan City, Taiwan, 73657

Recruiting

National Taiwan University Cancer Center (NTUCC)

Taipei City, Taiwan, 100229

Withdrawn

Taipei Tzu Chi General Hospital

Taipei City, Taiwan, 110

Recruiting

National Taiwan University Hospital

Taipei, Taiwan, 100

Recruiting

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Recruiting

Chang Gung Medical Foundation Linkou Chang Gung Memorial Hospital

Taoyuan City, Taiwan, 33308