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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
GS-1206
DrugAdministered Orally
Treatment groups
302 Participants
are divided into 2 treatment groupsGroup A: Part A: Dose EscalationExperimental treatment 1 intervention
Group B: Part B: Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)
Time frame
First dose up to 21 days post first dose2
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Time frame
First dose date up to 30 days post last dose (Up to 3 years)3
Percentage of Participants Experiencing Clinical Laboratory Abnormalities Based National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0.
Time frame
First dose date up to 30 days post last dose (Up to 3 years)Secondary outcomes
1
Plasma Concentrations of GS-1206 and its Metabolites After Single Dose and Repeated Dose Administration
Time frame
Predose and postdose up to end of treatment (up to 2 years)2
Pharmacokinetic (PK) Parameter: Cmax of GS-1206 and its Metabolites
Cmax is defined as the maximum observed concentration of drug
Time frame
Up to 2 years3
PK Parameter: Tmax of GS-1206 and its Metabolites
Tmax is defined as the time (observed time point) of Cmax
Time frame
Up to 2 years4
PK Parameter: AUC0-24h of GS-1206 and its Metabolites
AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov