Clinical Trial of HRS-4642 Plus SHR-A2102 in Patients With Advanced Solid Tumors

NCT ID: NCT06955390

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-12-01

Brief Summary

The purpose of this study is to observe and evaluate the efficacy and safety of HRS-4642 combined with SHR-A2102 in the treatment of advanced solid tumors

Detailed Description

This study is a prospective, single-arm, exploratory clinical trial. It plans to enroll patients with advanced solid tumors , treating them with HRS-4642 in combination with SHR-A2102. The entire study is divided into two stages: a safety run-in period and an efficacy exploration period.

Conditions

Solid Tumors

Study Design

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

Study Groups

Treatment group

SHR-A2102+HRS-4642

Group Type: EXPERIMENTAL

SHR-A2102+HRS-4642

Intervention Type: DRUG

A fixed dose was used for SHR-A2102,HRS-4642 can be dose adjusted.

Interventions

SHR-A2102+HRS-4642

A fixed dose was used for SHR-A2102,HRS-4642 can be dose adjusted.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements

2. The age of signing the informed consent is from 18 to 75 years old, regardless of gender

3. Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors

4. The ECOG score is 0 or 1

5. Expected survival ≥12 weeks

6. At least one measurable lesion according to RECIST v1.1 criteria

7. Good level of organ function

8. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods

Exclusion Criteria

1. subjects with uncontrolled or active brain metastasis；

2. subjects with clinical significant lung disease;

3. subjects with history of autoimmune diseases;

4. Known active hepatitis B or C infection;

5. Subjects with severe cardiovascular and cerebrovascular diseases

6. Uncontrolled tumor-related pain

7. Severe infections that require intravenous antibiotic, antiviral or antifungal control

8. Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion

9. Received anti-tumor therapy 4 weeks prior to initiation of study treatment.

10. Known allergic to any compound of SHR-A2102 or HRS-4642

11. Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiming Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

Henan Cancer Hospital

Locations

Henan Cancer Hospital

Zhengzhou, Henan, China

Countries

China

Central Contacts

Qiming Wang, Professor

Role: CONTACT

qimingwang1006@126.com

+8613783590691

Zhen He, Professor

Role: CONTACT

Facility Contacts

Zhen He, Professor

Role: primary

hezhenriver@126.com

13523530961

Other Identifiers

ST-HRS4642-SHRA2102

Identifier Type: -

Identifier Source: org_study_id