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This study will evaluate the safety, tolerability and pharmacokinetics of RC98 for injeciton in subjects with advanced malignant solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RC98 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RC98 | Drug | Participants will be allocated to one of the following dose groups: 0.003, 0.03, 0.3, 2.5, 5.0, 10.0, 15.0 and 20.0 mg/kg, and receive one treatment of RC98 followed by 28 days of dose limited toxicity (DLT) observation period. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events was assessed by investigator(s) according to NCI-CTCAE v4.03 | From the day of ICF sign to 28 days after the day of the last treatment |
| Maximum Tolerated dose of RC98 | The dose level in which >= 2 out of 6 patients have dose-limiting toxicity (DLT). The MTD is defined as the previous dose level. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR) | 15 months |
| Progression Free Survival (PFS) |
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Inclusion Criteria:
Cardiac ejection fraction ≥ 50 %. Hemoglobin ≥ 90g/L; Absolute neutrophil count ≥ 1.5×10^9 /L Platelets ≥ 100×10^9 /L; Total bilirubin ≤ 1.5× ULN and ≤ 1.5× ULN with hepatic metastasis; AST and ALT ≤ 2.5×ULN and ≤ 5 x ULN with hepatic metastasis; Serum creatinine ≤1.5×ULN; INR, APTT and PT ≤ 1.5× ULN; TSH or FT4 or FT3 in (1±10%) ULN.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Cancer Hospital | Tianjin | Tianjin Municipality | 300060 | China |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Progression-free Survival (PFS) (median) was determined using the number of months measured from the initial date of treatment to the date of documented progression, or the date of death (in the absence of progression) of participants. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
| 15 months |