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RecruitingLast updated: 3 January 2024

This study aims to learn about the safety and dosing of a new drug when given alone, or in combination with a drug called Zimberelimab, in people with advanced solid cancersA Phase 1 Study to Evaluate the Safety and Tolerability of GS-9911 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors

Clinical summary

Summary

This study has four parts, and is evaluating how safe, tolerable and effective a new drug (caleld GS-9911) is when given alone or in combination with an anti-PD-1 monoclonal antibody (called Zimberelimab). GS-9911 will be administered as an oral tablet, while zimberelimab will be administerewd intravenously. 

Part A will evalaute GS-9911 alone as monotherapy in escalating doses to determine the recommended dose for expansion.

Part B will evaluate GS-9911 as monotherapy at the recommended dose for expansion as determined in Part A.

Part C will evaluate escalating doses of GS-9911 in combination with zimberelimab.

Part D will evaluate GS-9911 at the recommended dose for expansion as determined in Part C, in combination with zimberelimab.

Conditions

This trial is treating patients with advanced solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Gilead Sciences

Scientific Title

A Phase 1 Study to Evaluate the Safety and Tolerability of GS-9911 as Monotherapy and in Combination With an Anti-PD-1 Monoclonal Antibody in Adults With Advanced Solid Tumors

Eligibility

Inclusion

  • Parts A, C, and D:

    • Participants with histologically or cytologically confirmed advanced solid tumors who have received, been intolerant to, or are ineligible for all treatments known to confer clinical benefit
  • Part B:

    • Participants whose cancer previously derived clinical benefit from immune checkpoint inhibitors, or who have advanced solid tumor types for which immune checkpoint inhibitors are considered the standard of care and who have received, been intolerant to, or are ineligible for all treatments known to confer clinical benefit
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Evaluable (Part A) or measurable (Parts B, C, and D) disease as per Response Criteria Evaluation in Solid Tumors (RECIST) v1.1 criteria
  • Adequate organ functions
  • Tissue requirement:

    • Parts A-D: must be willing to provide baseline tumor tissue prior to enrollment
    • Part A backfill cohorts: a biopsy should be obtained prior to treatment and on treatment, if safely feasible
  • Participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified methods of contraception

Exclusion

  • Positive serum pregnancy test or lactating female
  • History of intolerance, hypersensitivity, or treatment discontinuation due to life- threatening immune-related adverse events on prior immunotherapy
  • Receipt of the therapies listed below within the specified timeframe prior to planned Cycle 1 Day 1 including: major surgery (< 4 weeks), immunotherapy or biologic therapy (< 28 days), chemotherapy (< 21 days), targeted small molecule therapy (<14 days or 5 half-lives, whichever is sooner), hormonal or other adjunctive therapy (< 14 days), radiation therapy (< 21 days), live vaccine (< 28 days)
  • Any prior allogeneic tissue/solid organ transplantation, including allogeneic stem cell transplantation
  • Diagnosis of immunodeficiency, or requires systemic corticosteroids (> 10 mg of prednisone daily, or equivalent)
  • History of autoimmune disease or active autoimmune disease that has required systemic treatment within 2 years prior to the start of study drug
  • History of pneumonitis requiring treatment with corticosteroids, interstitial lung disease, drug-induced pneumonitis, or severe radiation pneumonitis (excluding localized radiation pneumonitis)
  • Active second malignancy. Note: individuals with a history of malignancy that have been completed treated, with no evidence of active cancer for 2 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence are allowed to enroll.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Symptomatic cardiovascular disease
  • Active serious infection requiring ongoing treatment
  • Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or HIV.
  • Symptomatic ascites or pleural effusion

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You are able to swallow medication by mouth.
  • 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 not spread to other parts of the body.
  • but it is not possible to perform surgery to remove it.
  • 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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