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To evaluate the efficacy and safety of LTC004 in combination with Toripalimab in 10 patients with advanced solid tumors resistant to first-line immunotherapy, all eligible subjects will receive LTC004 on day 1 of Week 1 and day 1 of week 3. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab regimen until disease progression, intolerance, informed withdrawal or up to 2 years of dosing, whichever occurred first.
All eligible subjects will receive LTC004 on day 1 of Week 1 and day 1 of week 3. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab regimen until disease progression, intolerance, informed withdrawal or up to 2 years of dosing, whichever occurred first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LTC004+Toripalimab | Experimental | Eligible subjects will receive LTC004 on day 1 of Week 1 and day 1 of week 3. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LTC004+Toripalimab | Drug | LTC004 on D1 of Week 1 and D1 of week 3. IV,90μg/kg. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab. LTC004:D3,iv,45μg/kg,Q3W. Toripalimab:D1,iv,240mg,Q3W. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Antitumor efficacy of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| DCR | Disease control rate of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy | up to 12 months |
| DOR | Duration of Response of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ning Li | Contact | 010-87788495 | cancergcp@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ning Li, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| C000656314 | toripalimab |
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| up to 12 months |
| PFS | Progression-Free Survival of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy | up to 12 months |
| OS | Overall Survival of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy | up to 12 months |