Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors

Solid Tumors Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06082960
• Other study ID #: GS-US-521-6317
• Status: Recruiting
• Phase: Phase 1
• Start date: October 9, 2023
• Est. completion date: November 2026

Study information

• Verified date: May 2024
• Source: Gilead Sciences
• Contact: Gilead Clinical Study Information Center
• Phone: 1-833-445-3230
• Email: GileadClinicalTrials[@]gilead.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• 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

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumors

Intervention

Drug:
• GS-9911
Tablets administered orally
• Zimberelimab
Administered intravenously

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Canada	University Health Network, Princess Margaret Cancer Centre	Toronto
United States	SCRI Oncology Partners	Nashville	Tennessee
United States	Smilow Cancer Hospital Phase 1 Unit	New Haven	Connecticut
United States	NEXT Oncology	San Antonio	Texas
United States	South Texas Accelerated Research Therapeutics, LLC	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Treatment-emergent Adverse Events		First dose date up to 90 days post last dose (up to 105 weeks)
Primary	Percentage of Participants With Treatment-emergent Serious Adverse Events		First dose date up to 90 days post last dose (up to 105 weeks)
Primary	Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) in Dose-escalation Cohorts		First dose date up to 3 weeks
Secondary	Plasma Concentration of GS-9911		Predose up to end of treatment (up to 105 weeks)
Secondary	Pharmacokinetic (PK) Parameter: Cmax of GS-9911	Cmax is defined the maximum observed plasma drug concentration.	Predose up to end of treatment (up to 105 weeks)
Secondary	PK Parameter: Tmax of GS-9911	Tmax is defined as the time to maximum observed concentration.	Predose up to end of treatment (up to 105 weeks)
Secondary	Area Under the Concentration-Time Curve (AUC) of GS-9911	AUC is defined as the area under the concentration versus time curve.	Predose up to end of treatment (up to 105 weeks)

External Links

•   Gilead Clinical Trials Website