Experimental pill GS-1206 takes aim at Hard-to-Treat solid tumors
NCT ID NCT07703878
First seen Jul 15, 2026 · Last updated Sep 09, 2026 · Updated 5 times
Summary
This study tests an experimental oral drug called GS-1206 in adults with advanced or metastatic solid tumors that have a specific genetic mutation. The main goals are to evaluate the drug's safety, tolerability, and how the body processes it. Participants must have tumors that have worsened after standard treatments or who cannot take those treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental oral drug called GS-1206
- What this could lead to
- If successful, this could lead to a new treatment option for people with certain solid tumors that have not responded to standard therapies.
- What could go wrong
- This is an early-phase trial focused on safety, so the drug may not shrink tumors or improve survival. Side effects are possible and not yet fully known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 302 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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/Exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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NEXT Oncology
RECRUITINGSan Antonio, Texas, 78229, United States
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NEXT Oncology Dallas
RECRUITINGTexas City, Texas, 75039, United States
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START Midwest, LLC
RECRUITINGGrand Rapids, Michigan, 49546, United States
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START San Antonio, LLC
RECRUITINGTexas City, Texas, 78229, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- First human test of BI 4060107 aims to find safe dose for Hard-to-Treat tumors
- Can a new drug shield kidneys from chemotherapy damage?
- Mining Responders' tumors for clues to a universal cancer therapy
- Proton boost radiotherapy aims to hit large tumors harder while sparing healthy tissue
- New antibody aims to preserve immune checkpoint while fighting cancer
- Engineered immune cells target two markers on Hard-to-Treat tumors