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 an open-label, single-arm study with dose-escalation and expansion phases to access ATG-008 combined with Toripalimab in patients with advanced solid tumors.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATG-008 and Toripalimab | Experimental | Toripalimab will be combined with ATG-008. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ATG-008 | Drug | Tablet |
| |
| Toripalimab |
| Measure | Description | Time Frame |
|---|---|---|
| MTD | Maximum Tolerated Dose | Within 21 days after dosing |
| RP2D | Recommended phase 2 dose | Within 21 days after dosing |
| ORR | Overall Response Rate | Through study completion (approximately 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Peak Plasma Concentration (Cmax) | Day 1 - Day 15 |
| AUC | Area under the plasma concentration versus time curve (AUC) | Day 1 - Day 15 |
Not provided
Inclusion Criteria:
Know and voluntarily sign informed consent.
Age 18-70 years old (including 18 and 70 years old), weight ≥45 Kg.
At least one measurable lesion according to the RECIST 1.1 and RANO evaluation criteria.
ECOG performance status score is 0 or 1.
Blood chemistry test results, meet the following results:
Adequate bone marrow function and meets the following results:
Except for hearing loss and hair loss, all toxicity caused by previous anti-tumor therapy must have returned to ≤ Grade 1 (according to NCI-CTCAE version 5.0).
Life expectancy is longer than 3 months.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zheng | Contact | +86 028-85423655 | lzheng2005618@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Li Zheng | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing Cancer Hospital | Recruiting | Chongqing | Chongqing Municipality | China |
Not provided
| ID | Term |
|---|---|
| C000656314 | toripalimab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
IV infusion |
|
| DOR | Duration from the first observation of at least PR to time of disease progression, or deaths due to disease progression, whichever occurs first. | 12 months |
| DCR | Disease Control Rate (DCR=CBR+Stable Disease[SD; for a minimum of 12 weeks]) | 12 months |
| PFS | Duration from start of study treatment to PD or death (regardless of cause), whichever comes first | 12 months |
| OS | The estimates of Kaplan-Meier | 12 months |
| West China of Sichuan University | Recruiting | Chengdu | Sichuan | 610000 | China |
|