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Not yet recruiting NCT07615413

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.

Phase I Interventional KRAS G12C Mutation Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HS-10541.
Who it may be relevant to
Registry conditions: KRAS G12C Mutation Advanced Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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.

Overview

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.

Interventions

  • Drug HS-10541
    HS-10541 will be administered orally once daily in a continuous regimen

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: From Cycle 1 Day 1 through Day 21. A cycle is 21 days.]
  • Adverse events (AEs) [Time frame: Approximately 1.5 years.]
  • Objective response rate (ORR) [Time frame: Approximately 1.5 years.]
  • Progression-free survival (PFS) [Time frame: Approximately 1.5 years]
Secondary outcome measures (10)
  • PK profile of HS-10541as monotherapy, or combination therapy [Time frame: Pre-dose and postdose up to end of treatment, approximately 1.5 years.]
  • PK profile of HS-10541as monotherapy, or combination therapy [Time frame: Pre-dose and postdose up to end of treatment, approximately 1.5 years]
  • PK profile of HS-10541as monotherapy, or combination therapy [Time frame: Pre-dose and postdose up to end of treatment, approximately 1.5 years]
  • PK profile of HS-10541as monotherapy, or combination therapy [Time frame: Pre-dose and postdose up to end of treatment, approximately 1.5 years.]
  • ORR [Time frame: Approximately 1.5 years.]
  • Disease control rate (DCR) [Time frame: Approximately 1.5 years.]
  • Duration of response (DoR) [Time frame: Approximately 1.5 years]
  • PFS [Time frame: Approximately 1.5 years]
  • Overall Survival (OS) [Time frame: Approximately 3 years.]
  • Adverse events (AEs) [Time frame: Approximately 1.5 years.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07615413 · HS-10541-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗