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To determine the safety, tolerability, and recommended dose (RP2D) of QLF32004 in patients with advanced malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLF32004 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLF32004 | Drug | In the phase, five dose groups were proposed.The frequency of administration was once a week, and the treatment cycle was 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-Limiting Toxicity (DLT) | 21 days | |
| Maximum Tolerated Dose (MTD) | 21 days | |
| Recommended Phase 2 Dose (RP2D) | 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Emergent Adverse Event (TEAE) | 21 days | |
| Maximum Observed Plasma Concentration (Cmax) | 21 days | |
| Serious Adverse Event (SAE) |
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Inclusion Criteria:
Exclusion Criteria:
16. Have a history of serious cardiovascular and cerebrovascular diseases; 17. Have active infection and currently require intravenous anti-infection therapy; 18. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 19. The patient is known to have a history of psychotropic drug abuse, alcoholism or drug abuse;A clear past history of neurological or psychiatric disorders, including epilepsy or dementia; 20. Patients with other serious physical or mental disorders or abnormal laboratory tests that may increase the risk of study participation or interfere with study results, and who are considered unsuitable for study participation by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Li | Contact | 021-38804518 | sunypclinicaltrial@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Recruiting | Shanghai | Shanghai Municipality | 200120 | China |
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| 12 month |
| Area Under The Curve (AUC) | 21 days |