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

PHASE1RECRUITING

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.

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Study details:

Part D allocation for 1 cohort will be randomized.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

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.

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.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-08-18

Primary completion: 2027-12-01

Study completion finish: 2027-12-01

Study type

TREATMENT

Phase

PHASE1

Trial ID

NCT05007782

Intervention or treatment

DRUG: GS-1811

DRUG: Zimberelimab

Conditions

• Advanced Solid Tumor

Condition: Advanced Solid Tumor
DRUG: GS-1811 and other drugs
Camperdown, New South Wales, Australia and more
Sponsor: Gilead Sciences

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Chris O'Brien Lifehouse

Research sites nearby

Select from list below to view details:

Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Part A - GS-1811 Dose Escalation Not Specified	DRUG: GS-1811 Administered Intravenously
EXPERIMENTAL: Part B - Mandatory Paired Tumor Biopsy Not Specified	DRUG: GS-1811 Administered Intravenously
EXPERIMENTAL: Part C: GS-1811 + Zimberelimab Dose Escalation Not Specified	DRUG: GS-1811 Administered Intravenously
EXPERIMENTAL: Part D: GS-1811 + Zimberelimab Dose Expansion Not Specified	DRUG: GS-1811 Administered Intravenously
EXPERIMENTAL: Part E: GS-1811 Monotherapy Dose Expansion Not Specified	DRUG: GS-1811 Administered Intravenously
EXPERIMENTAL: Part F: GS-1811 Monotherapy and In Combination With Zimberelimab In Select Dose and Schedule Not Specified	DRUG: GS-1811 Administered Intravenously

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Part A and C	Not Specified	Day 1 Through Day 21
Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0	Not Specified	First dose to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE v5.0	Not Specified	First dose to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for GS-1811	Not Specified	Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
PK Parameter: Minimum Observed Concentration (Cmin) for GS-1811	Not Specified	Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
PK Parameter: Time of Maximum Observed Concentration (Tmax) for GS-1811	Not Specified	Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
PK Parameter: Area Under the Concentration-time Curve (AUC) for GS-1811	Not Specified	Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Percentage of Participants who Developed Antidrug Antibody (ADA) Against GS-1811	Not Specified	Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Objective response rate (ORR) in Part D	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	Day 1 Up to End of Treatment (24 months)
Disease control rate (DCR)	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	Day 1 Up to End of Treatment (24 months)
Time to response (TTR)	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	Day 1 Up to End of Treatment (24 months)
Duration of response (DOR)	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.	Day 1 Up to End of Treatment (24 months)
Progression-free survival (PFS)	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	Day 1 Up to End of Treatment (24 months)

Frequently Asked Questions

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References

Clinical Trials Gov: Study of GS-1811 Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors