GS-1206 in adults with solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase trial evaluates the safety, tolerability, and potential anti-tumor activity of GS-1206 in adults with solid tumors that harbor a protocol-specified mutation. Part A enrolls patients with advanced or metastatic disease who have progressed after prior treatment or are intolerant to standard options, while Part B expands to additional tumor types defined by the protocol. Participants undergo treatment with GS-1206 and are monitored for adverse effects and signs of tumor response. Eligibility requires a tumor mutation confirmed by an approved test, and excludes recent use of certain investigational or anticancer therapies. The study is sponsored by Gilead Sciences with sites in Michigan and Texas.

Why it matters

Who can join: the full rules

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.

Where it's running

• START Midwest, LLC
  Grand Rapids, Michigan, United States Recruiting
• NEXT Oncology Dallas
  Dallas, Texas, United States Recruiting
• NEXT Oncology
  San Antonio, Texas, United States Recruiting
• START San Antonio, LLC
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Gilead Clinical Study Information Center
• Email: GileadClinicalTrials@gilead.com
• Phone: 1-833-445-3230 (GILEAD-0)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.