Solid Tumor
Conditions
Brief summary
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.
Interventions
DRUGGS-1206
Administered Orally
Sponsors
Gilead Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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. Key
Exclusion criteria
* Use of any of the therapies listed below within the specified time frames: 1. Investigational drugs (drugs not marketed for any indication) within 28 days prior to Cycle 1 Day 1. 2. Anticancer biologic agent or immunotherapy within 28 days prior to Cycle 1 Day 1. 3. Anticancer chemotherapy or targeted approved small molecule therapy within 21 days prior to Cycle 1 Day 1, or 42 days for nitrosoureas or mitomycin. 4. 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. 5. Major surgery (excluding minor procedures, eg, placement of vascular access, gastrointestinal/biliary stent, biopsy) within 28 days prior to Cycle 1 Day 1, and any toxicity or complications have recovered to Grade 1 or less. 6. Radiation therapy within 21 days prior to Cycle 1 Day 1. Exception: limited (eg, pain palliation) radiation therapy is allowed if any radiation associated toxicity is resolved to Grade 1 or less, and the radiation is not administered to a target lesion. Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) | First dose up to 21 days post first dose |
| 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. | First dose date up to 30 days post last dose (Up to 3 years) |
| Percentage of Participants Experiencing Clinical Laboratory Abnormalities Based National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0. | First dose date up to 30 days post last dose (Up to 3 years) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentrations of GS-1206 and its Metabolites After Single Dose and Repeated Dose Administration | Predose and postdose up to end of treatment (up to 2 years) | — |
| Pharmacokinetic (PK) Parameter: Cmax of GS-1206 and its Metabolites | Up to 2 years | Cmax is defined as the maximum observed concentration of drug |
| PK Parameter: Tmax of GS-1206 and its Metabolites | Up to 2 years | Tmax is defined as the time (observed time point) of Cmax |
| PK Parameter: AUC0-24h of GS-1206 and its Metabolites | Up to 2 years | AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 |
| Objective Response Rate (ORR) | Up to 3 years | ORR is defined as the percentage of participants who have measurable disease at baseline and have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and assessed by the investigator at the local site. |
| Duration of Response (DOR) | Up to 3 years | DOR is defined as the measurement from the time of first response (CR or PR) as assessed by the investigator at local site, per RECIST v1.1 until the date of first documented disease progression or death, whichever occurs first. |
| Best Overall Response (BOR) | Up to 3 years | BOR is defined as the best response recorded from first dosing date until disease progression identified by RECIST v1.1, death, or the participant discontinues study treatment, whichever occurs first. |
| Progression-Free Survival (PFS) | Up to 3 years | PFS is defined as the time from first dosing date until disease progression or death from any cause, whichever comes first as measured per RECIST v1.1. |
| Disease Control Rate (DCR) | Up to 3 years | DCR is defined as the measurement by the percentage of participants who achieve confirmed response of CR or PR or stable disease. |
Countries
United States
Contacts
CONTACTGilead Clinical Study Information Center
STUDY_DIRECTORGilead Study Director
Gilead Sciences
Outcome results
None listed