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Trial record 1 of 1 for:    GS-US-521-6317
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Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors

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ClinicalTrials.gov Identifier: NCT06082960
Recruitment Status : Recruiting
First Posted : October 13, 2023
Last Update Posted : January 30, 2024
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-9911 when given alone or in combination with an anti-programmed cell death protein 1 (PD-1) monoclonal antibody in participants with advanced solid tumors.

The primary objectives of this study are to:

  • Assess the safety and tolerability of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors
  • Identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended dose for expansion (RDE) of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: GS-9911 Drug: Zimberelimab Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 9, 2023
Estimated Primary Completion Date : November 2026
Estimated Study Completion Date : November 2026

Arm Intervention/treatment
Experimental: Part A: GS-9911 Monotherapy Dose Escalation
Participants will receive escalating doses of GS-9911 monotherapy.
Drug: GS-9911
Tablets administered orally

Experimental: Part B: GS-9911 Monotherapy Dose Expansion
Participants will receive GS-9911 monotherapy at the recommended dose for expansion (RDE) determined in Part A.
Drug: GS-9911
Tablets administered orally

Experimental: Part C: Dose Escalation: GS-9911 + Anti-PD-1 Monoclonal Antibody
Participants will receive escalating doses of GS-9911 in combination with an anti-PD-1 monoclonal antibody (zimberelimab).
Drug: GS-9911
Tablets administered orally

Drug: Zimberelimab
Administered intravenously

Experimental: Part D: Dose Expansion: GS-9911 + Anti-PD-1 Monoclonal Antibody
Participants will receive GS-9911 at RDE determined in Part C in combination with an anti-PD-1 monoclonal antibody (zimberelimab).
Drug: GS-9911
Tablets administered orally

Drug: Zimberelimab
Administered intravenously




Primary Outcome Measures :
  1. Percentage of Participants With Treatment-emergent Adverse Events [ Time Frame: First dose date up to 90 days post last dose (up to 105 weeks) ]
  2. Percentage of Participants With Treatment-emergent Serious Adverse Events [ Time Frame: First dose date up to 90 days post last dose (up to 105 weeks) ]
  3. Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts [ Time Frame: First dose date up to 3 weeks ]

Secondary Outcome Measures :
  1. Plasma Concentration of GS-9911 [ Time Frame: Predose up to end of treatment (up to 105 weeks) ]
  2. Pharmacokinetic (PK) Parameter: Cmax of GS-9911 [ Time Frame: Predose up to end of treatment (up to 105 weeks) ]
    Cmax is defined the maximum observed plasma drug concentration.

  3. PK Parameter: Tmax of GS-9911 [ Time Frame: Predose up to end of treatment (up to 105 weeks) ]
    Tmax is defined as the time to maximum observed concentration.

  4. Area Under the Concentration-Time Curve (AUC) of GS-9911 [ Time Frame: Predose up to end of treatment (up to 105 weeks) ]
    AUC is defined as the area under the concentration versus time curve.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • 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 Criteria:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06082960


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 ext (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
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United States, Tennessee
SCRI Oncology Partners Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
South Texas Accelerated Research Therapeutics, LLC Recruiting
San Antonio, Texas, United States, 78229
Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Canada
University Health Network, Princess Margaret Cancer Centre Recruiting
Toronto, Canada, M5G
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
Additional Information:
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT06082960    
Other Study ID Numbers: GS-US-521-6317
First Posted: October 13, 2023    Key Record Dates
Last Update Posted: January 30, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms