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A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors

4. september 2026 oppdatert av: Gilead Sciences

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

302

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Michigan
      • Grand Rapids, Michigan, Forente stater, 49546
        • Rekruttering
        • START Midwest, LLC
    • Texas
      • San Antonio, Texas, Forente stater, 78229
        • Rekruttering
        • NEXT Oncology
      • Texas City, Texas, Forente stater, 75039
        • Rekruttering
        • NEXT Oncology Dallas
      • Texas City, Texas, Forente stater, 78229
        • Rekruttering
        • START San Antonio, LLC

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Part A: Dose Escalation
Participants will receive escalating doses of GS-1206 monotherapy one time daily up to 35 cycles.
Administered Orally
Eksperimentell: Part B: Dose Expansion
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.
Administered Orally

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)
Tidsramme: First dose up to 21 days post first dose
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.
Tidsramme: First dose date up to 30 days post last dose (Up to 3 years)
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.
Tidsramme: First dose date up to 30 days post last dose (Up to 3 years)
First dose date up to 30 days post last dose (Up to 3 years)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Plasma Concentrations of GS-1206 and its Metabolites After Single Dose and Repeated Dose Administration
Tidsramme: Predose and postdose up to end of treatment (up to 2 years)
Predose and postdose up to end of treatment (up to 2 years)
Pharmacokinetic (PK) Parameter: Cmax of GS-1206 and its Metabolites
Tidsramme: Up to 2 years
Cmax is defined as the maximum observed concentration of drug
Up to 2 years
PK Parameter: Tmax of GS-1206 and its Metabolites
Tidsramme: Up to 2 years
Tmax is defined as the time (observed time point) of Cmax
Up to 2 years
PK Parameter: AUC0-24h of GS-1206 and its Metabolites
Tidsramme: Up to 2 years
AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24
Up to 2 years
Objective Response Rate (ORR)
Tidsramme: 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.
Up to 3 years
Duration of Response (DOR)
Tidsramme: 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.
Up to 3 years
Best Overall Response (BOR)
Tidsramme: 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.
Up to 3 years
Progression-Free Survival (PFS)
Tidsramme: 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.
Up to 3 years
Disease Control Rate (DCR)
Tidsramme: 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.
Up to 3 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Studieleder: Gilead Study Director, Gilead Sciences

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

17. juli 2026

Primær fullføring (Antatt)

1. september 2029

Studiet fullført (Antatt)

1. september 2029

Datoer for studieregistrering

Først innsendt

8. juli 2026

Først innsendt som oppfylte QC-kriteriene

8. juli 2026

Først lagt ut (Faktiske)

15. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

8. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

4. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • GS-US-723-7652

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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