Solid TumorPhase 1NCT07703878
A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors
A Phase 1 study testing GS-1206 in people with Solid Tumor, run by Gilead Sciences at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- GS-1206
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 4 sitesUnited States
- Study dates
- 17 Jul 2026to Sep 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Use of any of the therapies listed below within the specified time frames:
- 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.
- 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.
- 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/Exclusion criteria may apply.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
United States4 sites, 4 recruiting
- Recruiting
NEXT Oncology Dallas
Dallas, Texas, 75039
- Recruiting
START Midwest, LLC
Grand Rapids, Michigan, 49546
- Recruiting
NEXT Oncology
San Antonio, Texas, 78229
- Recruiting
START San Antonio, LLC
San Antonio, Texas, 78229
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of GS-1206 in Adults With Solid Tumors
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.
- Conditions
- Solid Tumor
- Being tested
- GS-1206
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-1206Drug
Administered Orally
| Study group | Role | What they receive |
|---|---|---|
| Part A: Dose Escalation | Experimental | Participants will receive escalating doses of GS-1206 monotherapy one time daily up to 35 cycles. Receives: Drug: GS-1206 |
| Part B: Dose Expansion | Experimental | 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. Receives: Drug: GS-1206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)
Measured: 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.
Measured: 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.
Measured: First dose date up to 30 days post last dose (Up to 3 years)
Secondary outcomes (9)
Plasma Concentrations of GS-1206 and its Metabolites After Single Dose and Repeated Dose Administration
Measured: Predose and postdose up to end of treatment (up to 2 years)
Pharmacokinetic (PK) Parameter: Cmax of GS-1206 and its Metabolites
Cmax is defined as the maximum observed concentration of drug
Measured: Up to 2 years
PK Parameter: Tmax of GS-1206 and its Metabolites
Tmax is defined as the time (observed time point) of Cmax
Measured: Up to 2 years
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
Measured: Up to 2 years
Objective Response Rate (ORR)
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.
Measured: Up to 3 years
Duration of Response (DOR)
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.
Measured: Up to 3 years
Best Overall Response (BOR)
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.
Measured: Up to 3 years
Progression-Free Survival (PFS)
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.
Measured: Up to 3 years
Disease Control Rate (DCR)
DCR is defined as the measurement by the percentage of participants who achieve confirmed response of CR or PR or stable disease.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start17 Jul 2026
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703878
- Sponsor's protocol ID
- GS-US-723-7652
- Status last verified
- Nov 2026
- First submitted
- 8 Jul 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability, and Antitumor Activity of GS-1206 in Adults With Solid Tumors
- ClinicalTrials.gov ID
- NCT07703878
- Acronym / sponsor ID
- GS-US-723-7652
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2026 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A: Dose Escalation | Experimental | Drug: GS-1206Participants will receive escalating doses of GS-1206 monotherapy one time daily up to 35 cycles. |
| Part B: Dose Expansion | Experimental | Drug: GS-1206Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (8 listed)
- Use of any of the therapies listed below within the specified time frames:
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-1206Administered Orally | Drug | Part A: Dose Escalation, Part B: Dose Expansion |
Primary outcome
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)
Time frame: 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.
Time frame: 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.
Time frame: First dose date up to 30 days post last dose (Up to 3 years)
9 secondary outcomes
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)
Pharmacokinetic (PK) Parameter: Cmax of GS-1206 and its Metabolites
Time frame: Up to 2 years
PK Parameter: Tmax of GS-1206 and its Metabolites
Time frame: Up to 2 years
PK Parameter: AUC0-24h of GS-1206 and its Metabolites
Time frame: Up to 2 years
Objective Response Rate (ORR)
Time frame: Up to 3 years
Duration of Response (DOR)
Time frame: Up to 3 years
Best Overall Response (BOR)
Time frame: Up to 3 years
Progression-Free Survival (PFS)
Time frame: Up to 3 years
Disease Control Rate (DCR)
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gilead Clinical Study Information Center contact
Gilead Study Director study director
Gilead Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-1206 in people with Solid Tumor, run by Gilead Sciences at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gilead Clinical Study Information Center (1-833-445-3230 (GILEAD-0), GileadClinicalTrials@gilead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) (time frame: First dose up to 21 days post first dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.