- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07703878
A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors
4. september 2026 opdateret af: 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.
Studieoversigt
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
302
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Gilead Clinical Study Information Center
- Telefonnummer: 1-833-445-3230 (GILEAD-0)
- E-mail: GileadClinicalTrials@gilead.com
Studiesteder
-
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Michigan
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Grand Rapids, Michigan, Forenede Stater, 49546
- Rekruttering
- START Midwest, LLC
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Texas
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San Antonio, Texas, Forenede Stater, 78229
- Rekruttering
- NEXT Oncology
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Texas City, Texas, Forenede Stater, 75039
- Rekruttering
- NEXT Oncology Dallas
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Texas City, Texas, Forenede Stater, 78229
- Rekruttering
- START San Antonio, LLC
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Part A: Dose Escalation
Participants will receive escalating doses of GS-1206 monotherapy one time daily up to 35 cycles.
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Administered Orally
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Eksperimentel: 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
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)
Tidsramme: First dose up to 21 days post first dose
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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)
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First dose date up to 30 days post last dose (Up to 3 years)
|
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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 |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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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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|
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Pharmacokinetic (PK) Parameter: Cmax of GS-1206 and its Metabolites
Tidsramme: Up to 2 years
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Cmax is defined as the maximum observed concentration of drug
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Up to 2 years
|
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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
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Up to 2 years
|
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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
|
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Objective Response Rate (ORR)
Tidsramme: Up to 3 years
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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.
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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
|
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Progression-Free Survival (PFS)
Tidsramme: Up to 3 years
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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.
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Up to 3 years
|
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Disease Control Rate (DCR)
Tidsramme: Up to 3 years
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DCR is defined as the measurement by the percentage of participants who achieve confirmed response of CR or PR or stable disease.
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Up to 3 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Gilead Study Director, Gilead Sciences
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
17. juli 2026
Primær færdiggørelse (Anslået)
1. september 2029
Studieafslutning (Anslået)
1. september 2029
Datoer for studieregistrering
Først indsendt
8. juli 2026
Først indsendt, der opfyldte QC-kriterier
8. juli 2026
Først opslået (Faktiske)
15. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- GS-US-723-7652
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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Ja
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