Study of GS-9911 With or Without Antibody Treatment for Adults With Solid Tumors
Running, not enrolling · Phase 1
Conditions studied: Solid Tumors
In brief
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
Key facts
- Study ID
- NCT06082960
- Run by
- Gilead Sciences
- People needed
- 45
- Starts
- 2023-10-09
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-04-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- 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.
Where it is running
- Smilow Cancer Hospital Phase 1 Unit — New Haven, Connecticut, United States
- SCRI Oncology Partners — Nashville, Tennessee, United States
- NEXT Oncology — San Antonio, Texas, United States
- South Texas Accelerated Research Therapeutics, LLC — San Antonio, Texas, United States
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia
- University Health Network, Princess Margaret Cancer Centre — Toronto, Canada
Full record on ClinicalTrials.gov
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