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.

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • HS-10541

Treatment groups

636 Participants
are divided into 1 treatment group

Locations

This trial has no locations