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 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
636
Phase
- La phase 1
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: HS-10541
Participants in all subjects will receive HS-10541
|
HS-10541 will be administered orally once daily in a continuous regimen
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Dose-limiting toxicity (DLT)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Adverse events (AEs)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: Approximately 3 years.
|
Defined as the time from date of first dose to the date of death due to any cause
|
Approximately 3 years.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
30 juin 2026
Achèvement primaire (Estimé)
30 juin 2029
Achèvement de l'étude (Estimé)
30 décembre 2029
Dates d'inscription aux études
Première soumission
14 mai 2026
Première soumission répondant aux critères de contrôle qualité
22 mai 2026
Première publication (Réel)
29 mai 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
29 mai 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
22 mai 2026
Dernière vérification
1 mai 2026
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- HS-10541-101
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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