Advanced Solid Tumor
Conditions
Brief summary
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.
Interventions
DRUGATG-008
Tablet
DRUGToripalimab
IV infusion
Sponsors
Sichuan University
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Know and voluntarily sign informed consent. 2. Age 18-70 years old (including 18 and 70 years old), weight ≥45 Kg. 3. At least one measurable lesion according to the RECIST 1.1 and RANO evaluation criteria. 4. ECOG performance status score is 0 or 1. 5. Blood chemistry test results, meet the following results: 1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × normal upper limit (ULN) 2. Total bilirubin ≤ 1.5 × ULN 3. Serum albumin\> 29 g / L 4. Creatinine ≤ 1.5 × ULN or 24-hour serum creatinine clearance ≥ 50 mL / min 5. Lipase and amylase ≤ 2 × ULN. 6. Adequate bone marrow function and meets the following results: 1. Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L 2. Platelets ≥ 75 × 10\^9 / L 3. Hemoglobin ≥ 90 g / L. 7. 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). 8. Life expectancy is longer than 3 months.
Exclusion criteria
1. Have a history of hepatic encephalopathy. 2. Have a thyroid disorder with a clinically significant thyroid dysfunction judged by the investigator (not applicable for thyroid cancer in dose expansion phase). 3. Active or history of upper gastrointestinal bleeding, ulcers, or esophageal varices with bleeding within 6 months. 4. Have a history of HIV infection and/or acquired immunodeficiency syndrome 5. Major surgery has been performed within 4 weeks before the first dose, or is expected during the study period. 6. Have a history of organ transplantation (eg., liver transplantation). 7. Poorly-controlled pleural or pericardial effusion during the screening period. 8. Other primary malignancies occurred within 5 years before the first administration of the study drug with the exception of locally curable malignancies 9. Suffering from active or previously recurring autoimmune diseases or under such a risk. 10. Systemically immunosuppressive drugs are currently used within 14 days of the first dose. 11. The investigator considers that the complications or other situations of the subject may affect compliance with the protocol, or are not suitable for participation in this study. 12. Subjects with diabetes or glycated hemoglobin (HbA1c)\> 7%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MTD | Within 21 days after dosing | Maximum Tolerated Dose |
| RP2D | Within 21 days after dosing | Recommended phase 2 dose |
| ORR | Through study completion (approximately 2 years) | Overall Response Rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR | 12 months | Disease Control Rate (DCR=CBR+Stable Disease\[SD; for a minimum of 12 weeks\]) |
| AUC | Day 1 - Day 15 | Area under the plasma concentration versus time curve (AUC) |
| OS | 12 months | The estimates of Kaplan-Meier |
| PFS | 12 months | Duration from start of study treatment to PD or death (regardless of cause), whichever comes first |
| DOR | 12 months | Duration from the first observation of at least PR to time of disease progression, or deaths due to disease progression, whichever occurs first. |
| Cmax | Day 1 - Day 15 | Peak Plasma Concentration (Cmax) |
Countries
China
Contacts
Primary ContactLi Zheng
Outcome results
None listed