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Study to Evaluate the Safety and Tolerability of GS-1811 as Monotherapy and in Combination With Pembrolizumab 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 : April 22, 2022
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

The primary objectives of this study are 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 pembrolizumab in participants with advanced solid tumors.

This study will be conducted in 2 phases, Phase 1a (Part A and Part B: monotherapy) and Phase 1b (Part C: 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 (Phase 1a and Phase 1b) and whose diseases are indicated for pembrolizumab monotherapy treatment (Phase 1b only).


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 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-1811, an Afucosylated Anti-CCR8 Monoclonal Antibody, as Monotherapy and in Combination With Pembrolizumab in Adults With Advanced Solid Tumors
Actual Study Start Date : August 18, 2021
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1a, Part A - GS-1811 Dose Escalation
Participants will receive escalating dose levels of GS-1811 for up to 12 months to determine maximum tolerated dose (MTD) and/or the recommended phase 2 dose (RP2D) of GS-1811.
Drug: GS-1811
Administered intravenously

Experimental: Phase 1a, Part B - Mandatory Paired Tumor Biopsy
Participants with select tumor types will receive GS-1811 at the dose deemed safe in Part A for up to 12 months.
Drug: GS-1811
Administered intravenously

Experimental: Phase 1b, Part C: GS-1811 + Pembrolizumab
Participants will receive GS-1811 at dose levels deemed safe in Part A in combination with pembrolizumab for up to 24 months.
Drug: GS-1811
Administered intravenously

Drug: Pembrolizumab
Administered intravenously
Other Name: KEYTRUDA®




Primary Outcome Measures :
  1. Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) [ 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 ]


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:

  • Histologically or cytologically confirmed advanced solid tumors

    • Part A: Individuals with advanced solid tumors who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit
    • Part B: Individuals with select indications who have received, been intolerant to, or been ineligible for all treatment known to confer clinical benefit
    • Part C: Individuals with 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 pembrolizumab monotherapy
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • 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:

    • Part A and Part C: 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

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
  • Concurrent active malignancy other than nonmelanoma skin cancer, carcinoma in situ of the cervix, 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) or any life-threatening hypersensitivity to 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
  • 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 Cycle 1, Day 1 (vector vaccines and messenger RNA (mRNA) vaccines are allowed)
  • 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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United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Mary Crowley Cancer Research Recruiting
Dallas, Texas, United States, 75230
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
United States, Wisconsin
University of Wisconsin Clinical Sciences Center Recruiting
Madison, Wisconsin, United States, 53705
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
First Posted: August 16, 2021    Key Record Dates
Last Update Posted: April 22, 2022
Last Verified: April 2022
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
Pembrolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents