Phase 1 Study of HS-10541 as Monotherapy or in Combination With Other Anti-cancer Therapies in Patients With KRAS G12C Mutation Advanced Solid Tumors.
22. mai 2026 oppdatert av: Jiangsu Hansoh Pharmaceutical Co., Ltd.
A Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10541 as Monotherapy or in Combination With Other Anti-cancer Therapies in Participants With KRAS G12C Mutation Advanced Solid Tumors.
This is a multicenter, open-label phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of HS-10541 as monotherapy or in combination with other anti-cancer therapies in participants with KRAS G12C mutation advanced solid tumors.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
636
Fase
- Fase 1
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
Inclusion Criteria:
- Voluntary participation and written informed consent..
- Aged 18 years or older (≥18 years), of any gender.
- Histologically or cytologically confirmed advanced solid tumor.
- At least one measurable lesion according to RECIST v1.1.
- ECOG PS of 0 to 1, with no deterioration within 2 weeks prior to the first dose.
- With a life expectancy > 12 weeks.
- Adequate bone marrow reserve and organ function.
- Female participants of childbearing potential and non-sterilized male participants must agree to use highly effective contraceptive measures from the time of signing the ICF until 6 months after the last dose.
- Female participants of childbearing potential must be non-lactating; all female participants must have a negative pregnancy test prior to the first dose.
Exclusion Criteria:
- Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.
- Presence of symptomatic brain metastases, leptomeningeal/brainstem involvement, history of intracranial hemorrhage or intraspinal hemorrhage, or spinal cord compression.
- Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
- History of a second primary malignancy
- Severe, uncontrolled, or active cardiovascular or cerebrovascular diseases, or severe cardiac examination abnormalities.
- Severe or poorly controlled diabetes mellitus or hypertension.
- Known active infectious diseases.
- Clinically significant gastrointestinal dysfunction.
- Gastrointestinal obstruction or perforation occured.
- Interstitial lung disease (ILD).
- Participants with known hypersensitivity or contraindications to any active or inactive ingredients of the study drug, chemically similar drugs, or drugs of the same class.
- Other inappropriate situation considered by the investigator.
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: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: HS-10541
Participants in all subjects will receive HS-10541
|
HS-10541 will be administered orally once daily in a continuous regimen
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Dose-limiting toxicity (DLT)
Tidsramme: From Cycle 1 Day 1 through Day 21. A cycle is 21 days.
|
Number of participants with dose limiting toxicities.
|
From Cycle 1 Day 1 through Day 21. A cycle is 21 days.
|
|
Adverse events (AEs)
Tidsramme: Approximately 1.5 years.
|
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from the date of first dose to 28 days (monotherapy) or 90 days (combination therapy) after the final dose (or as specified in the protocol).
|
Approximately 1.5 years.
|
|
Objective response rate (ORR)
Tidsramme: Approximately 1.5 years.
|
Defined as the percentage of participants with a best overall response of partial response or better per response evaluation criteria in solid tumors (RECIST 1.1).
|
Approximately 1.5 years.
|
|
Progression-free survival (PFS)
Tidsramme: Approximately 1.5 years
|
Defined as from the date of first dose to the date of disease progression according to investigator assessment or death due to any cause, whichever occurs first.
|
Approximately 1.5 years
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse events (AEs)
Tidsramme: Approximately 1.5 years.
|
Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) from the date of first dose to 28 days (monotherapy) or 90 days (combination therapy) after the final dose (or as specified in the protocol).
|
Approximately 1.5 years.
|
|
PK profile of HS-10541as monotherapy, or combination therapy
Tidsramme: Pre-dose and postdose up to end of treatment, approximately 1.5 years.
|
The maximum concentration (Cmax)
|
Pre-dose and postdose up to end of treatment, approximately 1.5 years.
|
|
PK profile of HS-10541as monotherapy, or combination therapy
Tidsramme: Pre-dose and postdose up to end of treatment, approximately 1.5 years
|
Time to the maximum concentration (Tmax)
|
Pre-dose and postdose up to end of treatment, approximately 1.5 years
|
|
PK profile of HS-10541as monotherapy, or combination therapy
Tidsramme: Pre-dose and postdose up to end of treatment, approximately 1.5 years
|
Area under the concentration time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC0-t)
|
Pre-dose and postdose up to end of treatment, approximately 1.5 years
|
|
PK profile of HS-10541as monotherapy, or combination therapy
Tidsramme: Pre-dose and postdose up to end of treatment, approximately 1.5 years.
|
Area under the concentration time curve from time zero to infinity (AUC0-∞)
|
Pre-dose and postdose up to end of treatment, approximately 1.5 years.
|
|
ORR
Tidsramme: Approximately 1.5 years.
|
Defined as the percentage of participants with a best overall response of partial response or better per response evaluation criteria in solid tumors (RECIST 1.1).
|
Approximately 1.5 years.
|
|
Disease control rate (DCR)
Tidsramme: Approximately 1.5 years.
|
Defined as the percentage of participants with a best overall response of stable disease or better per RECIST 1.1.
|
Approximately 1.5 years.
|
|
Duration of response (DoR)
Tidsramme: Approximately 1.5 years
|
Defined as the time from date of first documented evidence of partial response or better to the date of disease progression or death due to any cause
|
Approximately 1.5 years
|
|
PFS
Tidsramme: Approximately 1.5 years
|
Defined as from the date of first dose to the date of disease progression according to investigator assessment or death due to any cause, whichever occurs first.
|
Approximately 1.5 years
|
|
Overall Survival (OS)
Tidsramme: Approximately 3 years.
|
Defined as the time from date of first dose to the date of death due to any cause
|
Approximately 3 years.
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
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Studer hoveddatoer
Studiestart (Antatt)
30. juni 2026
Primær fullføring (Antatt)
30. juni 2029
Studiet fullført (Antatt)
30. desember 2029
Datoer for studieregistrering
Først innsendt
14. mai 2026
Først innsendt som oppfylte QC-kriteriene
22. mai 2026
Først lagt ut (Faktiske)
29. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
29. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- HS-10541-101
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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