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 maj 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
636
Fas
- Fas 1
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: HS-10541
Participants in all subjects will receive HS-10541
|
HS-10541 will be administered orally once daily in a continuous regimen
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dose-limiting toxicity (DLT)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Adverse events (AEs)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: Approximately 3 years.
|
Defined as the time from date of first dose to the date of death due to any cause
|
Approximately 3 years.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
30 juni 2026
Primärt slutförande (Beräknad)
30 juni 2029
Avslutad studie (Beräknad)
30 december 2029
Studieregistreringsdatum
Först inskickad
14 maj 2026
Först inskickad som uppfyllde QC-kriterierna
22 maj 2026
Första postat (Faktisk)
29 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
29 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- HS-10541-101
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