- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07703878
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
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
- Navn: Gilead Clinical Study Information Center
- Telefonnummer: 1-833-445-3230 (GILEAD-0)
- E-post: GileadClinicalTrials@gilead.com
Studiesteder
-
-
Michigan
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Grand Rapids, Michigan, Forente stater, 49546
- Rekruttering
- START Midwest, LLC
-
-
Texas
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San Antonio, Texas, Forente stater, 78229
- Rekruttering
- NEXT Oncology
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Texas City, Texas, Forente stater, 75039
- Rekruttering
- NEXT Oncology Dallas
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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:
- 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.
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
|
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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.
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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
|
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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)
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Predose and postdose up to end of treatment (up to 2 years)
|
|
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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
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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.
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Up to 3 years
|
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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
|
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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.
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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
|
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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.
Hjelpsomme linker
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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