Clinical trial NCT06955390: Clinical Trial of HRS-4642 Plus SHR-A2102 in Patients With Advanced Solid Tumors
Official title: An Exploratory Clinical Study of HRS-4642 in Combination With SHR-A2102 for the Treatment of Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2025-05-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Dose Limited Toxicity(DLT)
timeFrame: At the end of Cycle 1 (each cycle is 14 days)
measure: Objective Response Rate (ORR)
timeFrame: up to 1 year
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: up to 2 year
measure: Overall survival(OS)
timeFrame: up to 2 year
measure: Disease Control Rate (DCR)
timeFrame: up to 1 year
measure: Duration of response (DoR)
timeFrame: up to 1 year
measure: Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory
timeFrame: Begin from sign the ICF until the end of the safety follow-up period，Up to approximately 2 years.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Henan Cancer Hospital
name: Qiming Wang, Professor
role: PRINCIPAL_INVESTIGATOR
References: