A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGilead Sciences
About this trial
The goal of this clinical study is to learn more about the study drug GS-1206, including its safety, tolerability, and antitumor activity in adult participants with solid tumors.
Eligibility criteria
Qualifiers
All individuals must have a tumor with protocol-specified mutation as determined by local health-authority approved test.
For Part A (including backfill cohorts): Individuals with histologically confirmed advanced or metastatic solid tumors who have progressed following treatment in the advanced or metastatic setting known to confer clinical benefit, unless the individual refused, is intolerant to, or is not eligible for standard-of-care (SOC) treatment.
For Part B dose expansion, individuals with protocol-specified tumor types will be enrolled.
Disqualifiers
Investigational drugs (drugs not marketed for any indication) within 28 days prior to Cycle 1 Day 1.
Anticancer biologic agent or immunotherapy within 28 days prior to Cycle 1 Day 1.
Anticancer chemotherapy or targeted approved small molecule therapy within 21 days prior to Cycle 1 Day 1, or 42 days for nitrosoureas or mitomycin.
Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started within 14 days prior to planned Cycle 1 Day 1 are not permitted. Exceptions: hormonal therapy, bisphosphonates, somatostatin analogues, and leuprolide are permitted if started at least 14 days prior to Cycle 1 Day 1.
Trial design
Treatments tested in this trial
- GS-1206
Treatment groups
302 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov