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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 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

636

Fase

  • Fase 1

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Voluntary participation and written informed consent..
  2. Aged 18 years or older (≥18 years), of any gender.
  3. Histologically or cytologically confirmed advanced solid tumor.
  4. At least one measurable lesion according to RECIST v1.1.
  5. ECOG PS of 0 to 1, with no deterioration within 2 weeks prior to the first dose.
  6. With a life expectancy > 12 weeks.
  7. Adequate bone marrow reserve and organ function.
  8. 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.
  9. 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:

  1. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion requiring clinical intervention.
  2. Presence of symptomatic brain metastases, leptomeningeal/brainstem involvement, history of intracranial hemorrhage or intraspinal hemorrhage, or spinal cord compression.
  3. Unresolved CTCAE ≥grade 2 toxicities from previous anticancer therapy.
  4. History of a second primary malignancy
  5. Severe, uncontrolled, or active cardiovascular or cerebrovascular diseases, or severe cardiac examination abnormalities.
  6. Severe or poorly controlled diabetes mellitus or hypertension.
  7. Known active infectious diseases.
  8. Clinically significant gastrointestinal dysfunction.
  9. Gastrointestinal obstruction or perforation occured.
  10. Interstitial lung disease (ILD).
  11. 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.
  12. Other inappropriate situation considered by the investigator.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: HS-10541
Participants in all subjects will receive HS-10541
Geneesmiddel: HS-10541
HS-10541 will be administered orally once daily in a continuous regimen

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Dose-limiting toxicity (DLT)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adverse events (AEs)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: Approximately 3 years.
Defined as the time from date of first dose to the date of death due to any cause
Approximately 3 years.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 juni 2026

Primaire voltooiing (Geschat)

30 juni 2029

Studie voltooiing (Geschat)

30 december 2029

Studieregistratiedata

Eerst ingediend

14 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

22 mei 2026

Eerst geplaatst (Werkelijk)

29 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

29 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

22 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • HS-10541-101

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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