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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05007782
Recruitment Status : Recruiting
First Posted : August 16, 2021
Last Update Posted : May 24, 2024
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief 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 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.


Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: GS-1811 Drug: Zimberelimab Phase 1

Detailed Description:
Part D allocation for 1 cohort will be randomized.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 376 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, 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
Actual Study Start Date : August 18, 2021
Estimated Primary Completion Date : December 2027
Estimated Study Completion Date : December 2027

Arm Intervention/treatment
Experimental: Part A - GS-1811 Dose Escalation Drug: GS-1811
Administered Intravenously

Experimental: Part B - Mandatory Paired Tumor Biopsy Drug: GS-1811
Administered Intravenously

Experimental: Part C: GS-1811 + Zimberelimab Dose Escalation Drug: GS-1811
Administered Intravenously

Drug: Zimberelimab
Administered Intravenously

Experimental: Part D: GS-1811 + Zimberelimab Dose Expansion Drug: GS-1811
Administered Intravenously

Drug: Zimberelimab
Administered Intravenously

Experimental: Part E: GS-1811 Monotherapy Dose Expansion Drug: GS-1811
Administered Intravenously

Experimental: Part F: GS-1811 Monotherapy and In Combination With Zimberelimab In Select Dose and Schedule Drug: GS-1811
Administered Intravenously

Drug: Zimberelimab
Administered Intravenously




Primary Outcome Measures :
  1. Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Part A and C [ Time Frame: Day 1 Through Day 21 ]
  2. Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 [ Time Frame: First dose to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days ]
  3. Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE v5.0 [ Time Frame: First dose to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days ]

Secondary Outcome Measures :
  1. Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for GS-1811 [ Time Frame: Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days ]
  2. PK Parameter: Minimum Observed Concentration (Cmin) for GS-1811 [ Time Frame: Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days ]
  3. PK Parameter: Time of Maximum Observed Concentration (Tmax) for GS-1811 [ Time Frame: Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days ]
  4. PK Parameter: Area Under the Concentration-time Curve (AUC) for GS-1811 [ Time Frame: Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days ]
  5. Percentage of Participants who Developed Antidrug Antibody (ADA) Against GS-1811 [ Time Frame: Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days ]
  6. Objective response rate (ORR) in Part D [ Time Frame: Day 1 Up to End of Treatment (24 months) ]
    Objective response rate is defined as the proportion of participants who achieve complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  7. Disease control rate (DCR) [ Time Frame: Day 1 Up to End of Treatment (24 months) ]
    Disease control rate is defined as the proportion of participants who achieve CR, PR, or stable disease (SD) as assessed by RECIST Version 1.1

  8. Time to response (TTR) [ Time Frame: Day 1 Up to End of Treatment (24 months) ]
    Time to response is defined as the time from the first dose of GS-1811 in combination with Zimberelimab to the first documentation of CR or PR that is subsequently confirmed

  9. Duration of response (DOR) [ Time Frame: Day 1 Up to End of Treatment (24 months) ]
    Duration of response is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of definitive progressive disease (PD) or death from any cause, if applicable.

  10. Progression-free survival (PFS) [ Time Frame: Day 1 Up to End of Treatment (24 months) ]
    Progression-free survival is defined as the time from the first dose of GS-1811 in combination with Zimberelimab to the earlier of the first documentation of definitive PD or death from any cause



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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.

Key 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.


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): NCT05007782


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

Locations
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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: NCT05007782    
Other Study ID Numbers: GS-US-570-6015
2022-501684-40 ( Other Identifier: European Medicines Agency )
First Posted: August 16, 2021    Key Record Dates
Last Update Posted: May 24, 2024
Last Verified: May 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