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

Henan Cancer Hospital

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Solid Tumors

Treatments: Drug: SHR-A2102+HRS-4642

Study type: Interventional

Funder types: Other

Identifiers

NCT06955390

ST-HRS4642-SHRA2102

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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32 participants in 1 patient group

Treatment group

Experimental group

Description:

SHR-A2102+HRS-4642

Treatment:

Drug: SHR-A2102+HRS-4642