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

NCT ID: NCT05533463

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-21
• Study Completion Date: 2025-12-30

Brief Summary

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

Conditions

Advanced KRAS G12D Mutant Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HRS-4642

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.

Group Type: EXPERIMENTAL

HRS-4642

Intervention Type: DRUG

HRS-4642 will be administrated per dose level in which the patients are assigned.

Interventions

HRS-4642

HRS-4642 will be administrated per dose level in which the patients are assigned.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

2. Male or female ≥ 18 years old.

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

4. ECOG performance status of 0-1.

5. With a life expectancy of ≥3 months.

6. Have at least one measurable lesion.

7. Adequate laboratory parameters during the screening period

Exclusion Criteria

1. Previously received KRAS G12D inhibitors

2. Priot radiotherapy within 28 days for non-thoracic radiation

3. Prior anti-tumor chemotherapy (< 6 weeks if chemotherapy including nitrosoureas or mitomycin) within 4 weeks before the study drug administration

5. Central nervous system (CNS) metastases

6. Major surgical therapy within 28 days prior to the date of signature of informed consent form, or expected major surgery during the study.

7. Known history of hypersensitivity to any components of HRS-4642.

8. Other factors that may affect the study results or lead to forced termination of the study early as judged by investigators.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

HRS-4642-I-101

Identifier Type: -

Identifier Source: org_study_id