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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.

ConditionKRAS G12C Mutation Advanced Solid Tumor
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • HS-10541

    Drug

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

Treatment groups

636 Participants
are divided into 1 treatment group
Group A: HS-10541Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Number of participants with dose limiting toxicities.

Time frame
From Cycle 1 Day 1 through Day 21. A cycle is 21 days.
2

Adverse events (AEs)

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).

Time frame
Approximately 1.5 years.
3

Objective response rate (ORR)

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).

Time frame
Approximately 1.5 years.
4

Progression-free survival (PFS)

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.

Time frame
Approximately 1.5 years

Secondary outcomes

1

PK profile of HS-10541as monotherapy, or combination therapy

The maximum concentration (Cmax)

Time frame
Pre-dose and postdose up to end of treatment, approximately 1.5 years.
2

PK profile of HS-10541as monotherapy, or combination therapy

Time to the maximum concentration (Tmax)

Time frame
Pre-dose and postdose up to end of treatment, approximately 1.5 years
3

PK profile of HS-10541as monotherapy, or combination therapy

Area under the concentration time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC0-t)

Time frame
Pre-dose and postdose up to end of treatment, approximately 1.5 years
4

PK profile of HS-10541as monotherapy, or combination therapy

Area under the concentration time curve from time zero to infinity (AUC0-∞)

Time frame
Pre-dose and postdose up to end of treatment, approximately 1.5 years.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: