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This is a phase II clinical study to evaluate the safety, tolerability and preliminary antitumor activity of LTC004 in patients with locally advanced or metastatic sarcoma;Enrollment of 10 evaluable subjects in Phase I. If ≥2 subjects experience objective remission or SD lasting >12 weeks, proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PHASE 1 | Experimental | Enrollment of 10 consecutive evaluable sarcoma subjects with failure of existing standard therapy or lack of effective treatment Treated with LTC004 in Phase I |
|
| PHASE 2 | Experimental | If ≥2 subjects experience objective remission or SD lasting >12 weeks in PHASE 1, proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LTC004 | Drug | LTC004,45μg/kg,IV,Day 1,Q3W; |
|
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Antitumor efficacy of LTC004 treated sarcoma patients | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| DOR | Duration of Response of LTC004 treated sarcoma patients | up to 12 months |
| PFS rate | 12 weeks and 24 weeks Progression-Free Survival rate of LTC004 treated sarcoma patients |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| up to 12 months |
| OS | Overall Survival of LTC004 treated sarcoma patients | up to 12 months |