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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05007782




Registration number
NCT05007782
Ethics application status
Date submitted
11/08/2021
Date registered
16/08/2021
Date last updated
24/05/2024

Titles & IDs
Public title
Study of GS-1811 Given Alone or With Zimberelimab in Adults With Advanced Solid Tumors
Scientific 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
Secondary ID [1] 0 0
2022-501684-40
Secondary ID [2] 0 0
GS-US-570-6015
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GS-1811
Treatment: Drugs - Zimberelimab

Experimental: Part A - GS-1811 Dose Escalation -

Experimental: Part B - Mandatory Paired Tumor Biopsy -

Experimental: Part C: GS-1811 + Zimberelimab Dose Escalation -

Experimental: Part D: GS-1811 + Zimberelimab Dose Expansion -

Experimental: Part E: GS-1811 Monotherapy Dose Expansion -

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


Treatment: Drugs: GS-1811
Administered Intravenously

Treatment: Drugs: Zimberelimab
Administered Intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs) in Part A and C
Timepoint [1] 0 0
Day 1 Through Day 21
Primary outcome [2] 0 0
Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Timepoint [2] 0 0
First dose to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Primary outcome [3] 0 0
Percentage of Participants Experiencing Laboratory Abnormalities According to the NCI CTCAE v5.0
Timepoint [3] 0 0
First dose to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Secondary outcome [1] 0 0
Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax) for GS-1811
Timepoint [1] 0 0
Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Secondary outcome [2] 0 0
PK Parameter: Minimum Observed Concentration (Cmin) for GS-1811
Timepoint [2] 0 0
Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Secondary outcome [3] 0 0
PK Parameter: Time of Maximum Observed Concentration (Tmax) for GS-1811
Timepoint [3] 0 0
Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Secondary outcome [4] 0 0
PK Parameter: Area Under the Concentration-time Curve (AUC) for GS-1811
Timepoint [4] 0 0
Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Secondary outcome [5] 0 0
Percentage of Participants who Developed Antidrug Antibody (ADA) Against GS-1811
Timepoint [5] 0 0
Day 1 Up to End of Treatment (up to 12 months for monotherapy and 24 months for combination therapy) plus 90 days
Secondary outcome [6] 0 0
Objective response rate (ORR) in Part D
Timepoint [6] 0 0
Day 1 Up to End of Treatment (24 months)
Secondary outcome [7] 0 0
Disease control rate (DCR)
Timepoint [7] 0 0
Day 1 Up to End of Treatment (24 months)
Secondary outcome [8] 0 0
Time to response (TTR)
Timepoint [8] 0 0
Day 1 Up to End of Treatment (24 months)
Secondary outcome [9] 0 0
Duration of response (DOR)
Timepoint [9] 0 0
Day 1 Up to End of Treatment (24 months)
Secondary outcome [10] 0 0
Progression-free survival (PFS)
Timepoint [10] 0 0
Day 1 Up to End of Treatment (24 months)

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2027
Actual
Sample size
Target
376
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [2] 0 0
Monash Medical Centre - Clayton
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Tennessee
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
United States of America
State/province [6] 0 0
Wisconsin
Country [7] 0 0
Canada
State/province [7] 0 0
Toronto
Country [8] 0 0
Spain
State/province [8] 0 0
Madrid
Country [9] 0 0
Spain
State/province [9] 0 0
Pamplona
Country [10] 0 0
Taiwan
State/province [10] 0 0
Changhua
Country [11] 0 0
Taiwan
State/province [11] 0 0
Tainan City
Country [12] 0 0
Taiwan
State/province [12] 0 0
Taipei City
Country [13] 0 0
Taiwan
State/province [13] 0 0
Taipei
Country [14] 0 0
Taiwan
State/province [14] 0 0
Taoyuan City

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05007782
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gilead Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-833-445-3230 (GILEAD-0)
Fax 0 0
Email 0 0
GileadClinicalTrials@gilead.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05007782