Phase I Study of HRS-4642 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutation

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

No Placebo Group

Trial Summary

What is the purpose of this trial?

The study is being conducted to evaluate the safety and tolerability of HRS-4642 in patients with advanced solid tumors harboring KRAS G12D mutation.To estimate the maximum tolerated dose (MTD) and/or a biologically active dose (eg, recommended phase 2 dose \[RP2D\]) within investigated subject population groups

Eligibility Criteria

Inclusion Criteria

Histologically confirmed diagnosis of advanced solid tumor harbouring with KRAS G12D mutation

Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.

Male or female ≥ 18 years old.

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Treatment Details

Interventions

HRS-4642 (Small Molecule)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: HRS-4642Experimental Treatment1 Intervention

In Dose Escalation: HRS-4642 will be injected QW. Six dose levels are preset. In Dose Expansion: 1 to 2 dose cohorts will be selected for dose expansion stage. In Indication Expansion: Enrollment into the dose expansion cohorts may be from any eligible solid tumor type.