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The study is being conducted to evaluate the efficacy and safety of HRS-4508 in subjects with advanced or metastatic solid tumors and explore the reasonable dosage of HRS-4508.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group: HRS-4508 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-4508 | Drug | HRS-4508 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoints: Number of subjects with adverse events and the severity of adverse events | every 4 weeks after treatment initiation (through study completion, an average 5 mouths) | |
| DLT (Dose-limiting toxicity) | during the first 21-day cycle of HRS-4508 treatment | |
| MTD (Maximum tolerated dose) | 3 weeks after treatment initiation | |
| RP2D (Recommended Phase II Dose) | 3 weeks after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| ORR (Objective response rate - RECIST 1.1) | ORR is defined as the proportion of subjects who have achieved complete response (CR) or partial response (PR) according to RECIST 1.1. | Up to approximately 6 months |
| DoR (Duration of Response per RECIST 1.1) |
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Inclusion Criteria:
Patients must be willing to participate in the study, sign the informed consent form, have good compliance, and cooperate with follow-up visits.
Aged 18-75 years, male or female.
Patients with advanced malignant tumors confirmed pathologically;
Failure of adequate standard treatment, or no effective standard treatment;
Patients must have at least 1 extracranial measurable target lesion per RECIST v1.1;
The expected survival period is more than 12 weeks;
The Eastern Cooperative Oncology Group (ECOG) physical fitness score is 0-1;
Have sufficient bone marrow and organ function (have not received blood transfusion or hematopoietic stimulating factor treatment within 14 days):
ANC≥1.5 ×10e9/L; PLT≥100 × 10e9/L; Hb≥ 90 g/L; Cr)≤1.5 × times the upper limit of normal (ULN) or Clcr≥ 60 mL/min; LVEF≥50%; TBIL≤1.5 × times the upper limit of normal (ULN) ; ALT and AST ≤3×times the upper limit of normal (ULN)(Patients with liver metastasis, ≤5×ULN); International normalized ratio (INR) ≤ 1.5, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 times ULN.
Female subjects of childbearing age must undergo a serum pregnancy test within 7 days before starting the study medication, and the result is negative, and are willing to use a medically approved high-efficiency contraception during the study period and within 1 months after the last administration of the study drug Measures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoyu Zhu | Contact | 0518-82342973 | xiaoyu.zhu@hengrui.com | |
| Yueling Wang | Contact | 021-60453139 | yueling.wang@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | China |
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monotherapy
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| Up to approximately 2 years |
| DCR (Disease control rate-RECIST 1.1) | DCR is defined as the proportion of subjects who have achieved stable disease(SD)、complete response (CR) or partial response (PR) according to RECIST 1.1. | Up to approximately 2 years |
| PFS | Progression-free survival per RECIST 1.1 | Up to approximately 2 years |