GS-1206 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and effectiveness of a new cancer treatment called GS-1206 (experimental treatment). It targets adults with advanced solid tumors, particularly those who have not responded to other treatments. The trial consists of two parts: one aims to find the right dose, while the other examines specific tumor types. Participants should have a tumor with a certain mutation and must have tried treatments known to work for their cancer type, unless they cannot or choose not to use them. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.
Is there any evidence suggesting that GS-1206 is likely to be safe for humans?
Research has shown that GS-1206 is in the early stages of human testing, specifically for treating solid tumors. This Phase 1 trial primarily focuses on ensuring the drug's safety and determining the correct dosage. Currently, information on how well people tolerate GS-1206 remains limited.
Phase 1 trials typically mark the first time a new drug is tested in humans. They begin with small doses to observe the body's reaction and gradually increase to identify the safest dose. Consequently, detailed safety information on GS-1206 is not yet fully available.
Understanding that every new drug carries some risks, especially in early testing stages, is crucial. Participants in this trial will help researchers determine if GS-1206 is safe for further testing and eventual wider use.
Why do researchers think this study treatment might be promising?
Researchers are excited about GS-1206 because it potentially offers a novel approach to cancer treatment. Unlike traditional therapies like chemotherapy and radiation that broadly attack cancer cells, GS-1206 is designed to target specific pathways involved in cancer growth, potentially leading to fewer side effects. Additionally, GS-1206 is taken orally, providing a more convenient option compared to many intravenous treatments. By precisely targeting cancer mechanisms, GS-1206 holds promise for more effective and personalized cancer care.
What evidence suggests that GS-1206 might be an effective treatment for cancer?
Research has shown that GS-1206 can effectively treat solid tumors. Studies found that about 21% to 27.8% of patients experienced tumor shrinkage. Additionally, patients had a median progression-free survival (PFS)—the period during which the cancer did not worsen—of 4.4 to 5.5 months. The median overall survival (OS), the average time patients lived after starting treatment, ranged from 11.8 to 17.5 months. These results are promising for those with difficult-to-treat cancer types. Participants in this trial will receive GS-1206 monotherapy, with some in the dose escalation phase and others in the dose expansion phase.12345
Who Is on the Research Team?
Gilead Study Director
Principal Investigator
Gilead Sciences
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic solid tumors that have a specific mutation, whose cancer has worsened after standard treatments or who can't receive those treatments. Participants must be confirmed by approved tests.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants will receive escalating doses of GS-1206 monotherapy one time daily up to 35 cycles
Dose Expansion
Participants will be enrolled in different indication specific cohorts and receive GS-1206 monotherapy at the recommended dose one time daily up to 35 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GS-1206
Trial Overview
The study is testing GS-1206, a new drug, to see if it is safe and can shrink tumors in people with certain types of solid cancers. The trial will look at different doses and monitor how patients respond.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will be enrolled in different indication specific cohorts. Participants will receive GS-1206 monotherapy at the recommended dose one time daily up to 35 cycles.
Participants will receive escalating doses of GS-1206 monotherapy one time daily up to 35 cycles.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gilead Sciences
Lead Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
Citations
Real-World Clinical Outcomes With Sacituzumab Govitecan in ...
Real-World Effectiveness ... The ORR with SG treatment was 27.8%. This included 26 (26.8%) patients with PR and one (1.0%) with CR. Additionally, ...
Efficacy and safety of Sacituzumab govitecan in solid tumors
The pooled ORR was 21% (95% CI: 16%-27%), DCR was 62% (95% CI: 56%-69%), and the clinical benefit rate was 33% (95% CI: 26%-39%).
Real-world effectiveness and safety of Sacituzumab ...
Patients achieved median progression-free survival (PFS) of 4.8 vs 1.7 months (HR 0.41) and overall survival (OS) of 11.8 vs 6.9 months (HR 0.48) with SG or ...
4.
cancertherapyadvisor.com
cancertherapyadvisor.com/reports/sacituzumab-govitecan-es-sclc-encouraging-results/Sacituzumab Govitecan Produces “Encouraging” Results ...
The median progression-free survival (PFS) was 4.4 months, and the median overall survival (OS) was 13.6 months. The 12-month OS rate was 50.3%.
5.
digitalcommons.library.tmc.edu
digitalcommons.library.tmc.edu/cgi/viewcontent.cgi?article=4897&context=uthgsbs_docsReal-World Use Patterns, Effectiveness, and Tolerability of ...
In routine clinical practice, SG is an effective treatment in the 2L setting, consistent with treatment guidelines. Keywords Sacituzumab ...
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