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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/NCT06082960




Registration number
NCT06082960
Ethics application status
Date submitted
9/10/2023
Date registered
13/10/2023
Date last updated
16/05/2024

Titles & IDs
Public title
Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors
Scientific 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
Secondary ID [1] 0 0
GS-US-521-6317
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GS-9911
Treatment: Drugs - Zimberelimab

Experimental: Part A: GS-9911 Monotherapy Dose Escalation - Participants will receive escalating doses of GS-9911 monotherapy.

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.

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).

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).


Treatment: Drugs: GS-9911
Tablets administered orally

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 With Treatment-emergent Adverse Events
Timepoint [1] 0 0
First dose date up to 90 days post last dose (up to 105 weeks)
Primary outcome [2] 0 0
Percentage of Participants With Treatment-emergent Serious Adverse Events
Timepoint [2] 0 0
First dose date up to 90 days post last dose (up to 105 weeks)
Primary outcome [3] 0 0
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts
Timepoint [3] 0 0
First dose date up to 3 weeks
Secondary outcome [1] 0 0
Plasma Concentration of GS-9911
Timepoint [1] 0 0
Predose up to end of treatment (up to 105 weeks)
Secondary outcome [2] 0 0
Pharmacokinetic (PK) Parameter: Cmax of GS-9911
Timepoint [2] 0 0
Predose up to end of treatment (up to 105 weeks)
Secondary outcome [3] 0 0
PK Parameter: Tmax of GS-9911
Timepoint [3] 0 0
Predose up to end of treatment (up to 105 weeks)
Secondary outcome [4] 0 0
Area Under the Concentration-Time Curve (AUC) of GS-9911
Timepoint [4] 0 0
Predose up to end of treatment (up to 105 weeks)

Eligibility
Key inclusion criteria
Key

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

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
9/10/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Canada
State/province [4] 0 0
Toronto

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

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/ct2/show/NCT06082960
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
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/NCT06082960