Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a phase II clinical study to evaluate the safety and antitumor activity of LTC004 in patients with locally advanced or metastatic CRC,Enrollment of 10 evaluable subjects in Phase I. If ≥2 subjects experience objective remission,proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PHASE 1 | Experimental | Enrollment of 10 consecutive evaluable CRC 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 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 CRC patients | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| DOR | Duration of Response of LTC004 treated CRC patients | up to 12 months |
| PFS | Progression-Free Survival of LTC004 treated sarcoma patients |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 12 months |
| OS | Overall Survival of LTC004 treated CRC patients | up to 12 months |