Status:
UNKNOWN
ATG-008 Combined With Toripalimab in Advanced Solid Tumors
Lead Sponsor:
Sichuan University
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × normal upper limit (ULN)
- Total bilirubin ≤ 1.5 × ULN
- Serum albumin\> 29 g / L
- Creatinine ≤ 1.5 × ULN or 24-hour serum creatinine clearance ≥ 50 mL / min
- Lipase and amylase ≤ 2 × ULN.
- Adequate bone marrow function and meets the following results:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L
- Platelets ≥ 75 × 10\^9 / L
- Hemoglobin ≥ 90 g / L.
- 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
- Have a history of hepatic encephalopathy.
- Have a thyroid disorder with a clinically significant thyroid dysfunction judged by the investigator (not applicable for thyroid cancer in dose expansion phase).
- Active or history of upper gastrointestinal bleeding, ulcers, or esophageal varices with bleeding within 6 months.
- Have a history of HIV infection and/or acquired immunodeficiency syndrome
- Major surgery has been performed within 4 weeks before the first dose, or is expected during the study period.
- Have a history of organ transplantation (eg., liver transplantation).
- Poorly-controlled pleural or pericardial effusion during the screening period.
- Other primary malignancies occurred within 5 years before the first administration of the study drug with the exception of locally curable malignancies
- Suffering from active or previously recurring autoimmune diseases or under such a risk.
- Systemically immunosuppressive drugs are currently used within 14 days of the first dose.
- 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.
- Subjects with diabetes or glycated hemoglobin (HbA1c)\> 7%.
Key Trial Info
Start Date :
April 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04337463
Start Date
April 23 2020
End Date
December 1 2022
Last Update
May 17 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
2
West China of Sichuan University
Chengdu, Sichuan, China, 610000