Status:
NOT_YET_RECRUITING
Clinical Trial of HRS-4642 Plus SHR-A2102 in Patients With Advanced Solid Tumors
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
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 stud...
Eligibility Criteria
Inclusion
- 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
- The age of signing the informed consent is from 18 to 75 years old, regardless of gender
- Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors
- The ECOG score is 0 or 1
- Expected survival ≥12 weeks
- At least one measurable lesion according to RECIST v1.1 criteria
- Good level of organ function
- Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods
Exclusion
- subjects with uncontrolled or active brain metastasis；
- subjects with clinical significant lung disease;
- subjects with history of autoimmune diseases;
- Known active hepatitis B or C infection;
- Subjects with severe cardiovascular and cerebrovascular diseases
- Uncontrolled tumor-related pain
- Severe infections that require intravenous antibiotic, antiviral or antifungal control
- Clinically symptomatic moderate to severe ascites; Uncontrollable or moderate or above pleural effusion, pericardial effusion
- Received anti-tumor therapy 4 weeks prior to initiation of study treatment.
- Known allergic to any compound of SHR-A2102 or HRS-4642
- Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06955390
Start Date
May 1 2025
End Date
December 1 2026
Last Update
May 2 2025
Active Locations (1)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China