Solid Tumors
Conditions
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.
Interventions
DRUGSHR-A2102+HRS-4642
A fixed dose was used for SHR-A2102,HRS-4642 can be dose adjusted.
Sponsors
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limited Toxicity(DLT) | At the end of Cycle 1 (each cycle is 14 days) | one or more unacceptable toxic reactions that occur after administration, leading to an inability to further increase the dose or extend the dosing cycle. |
| Objective Response Rate (ORR) | up to 1 year | the proportion of patients with a confirmed complete response or partial response on two consecutive occasions≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease Control Rate (DCR) | up to 1 year | the proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD) |
| Progression-free Survival (PFS) | up to 2 year | the time from treatment initiation to the first disease progression or death from any cause |
| Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory | Begin from sign the ICF until the end of the safety follow-up period，Up to approximately 2 years. | Assess safety and tolerability by way of adverse events (CTCAE v5.0) |
| Duration of response (DoR) | up to 1 year | Assessed by Investigator According to RECIST v1.1 |
| Overall survival(OS) | up to 2 year | the time from treatment initiation until death from any reason |
Countries
China
Contacts
Primary ContactQiming Wang, Professor
Backup ContactZhen He, Professor
Outcome results
None listed