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RecruitingLast updated: 2 February 2024

GS-US-570-6015: This study is recruiting people with advanced solid cancers to study how safe and tolerable a new drug called GS-1811 is when given alone and when given in combination with immunotherapyA 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

Clinical summary

Summary

This study will be conducted in 5 parts (Parts A, B, and E: monotherapy, Parts C and D: combination therapy), in participants with advanced solid cancers who have received, been intolerant to, or been ineligible for all treatments known to benefit their disease. All of the arms are experimental. In Experimental Arm A (dose escalation), GS-1811 will be administered alone intravenously. In Experimental Arm B (mandatory paired tumour biopsy), GS-1811 will be administered intravenously. In Experimental Arm C (dose escalation), GS-1811 + zimberelimab will be administered intravenously. In Experimental Arm D (dose expansion), the dose of GS-1811 in previous parts will be further tested. GS-1811 and zimberelimab will be administered intravenously. In Experimental Arm E, the dose of GS-1811 in previous parts will be further tested. In this arm, participants will receive GS-1811 alone, intravenously.

Conditions

This trial is treating patients with advanced solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

GS-US-570-6015

More information

Trial Identifiers

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Trial sponsor

Gilead Sciences, Inc.

Scientific 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

Eligibility

Inclusion

  • 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 treatment known to confer clinical benefit or whose disease is indicated for anti-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.
  • 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 and E.
  • 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 and E: Must provide pre-treatment adequate tumor tissue sample prior to enrolment.
    • Part B: Must have fresh pre-treatment and on-treatment biopsy for biomarker analysis.

Exclusion

  • 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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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