ATG-008 Combined With Toripalimab in Advanced Solid Tumors
NCT ID: NCT04337463
Last Updated: 2021-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2020-04-23
2022-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of LTC004 Combine With Toripalimab in Patient With Solid Tumors Resistant to Immunotherapy
NCT06490068
A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors
NCT05718895
A Study of LM-108 as Monotherapy or in Combination With Antitumor Therapies in Subjects With Advanced Solid Tumors
NCT05518045
A Study of LM-108 in Combination With Toripalimab in Subjects With Advanced Solid Tumours
NCT06873854
Toripalimab Combined With Chemotherapy in Primary Tracheal Squamous Cell Carcinoma
NCT04716751
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ATG-008 and Toripalimab
Toripalimab will be combined with ATG-008.
ATG-008
Tablet
Toripalimab
IV infusion
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ATG-008
Tablet
Toripalimab
IV infusion
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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%.
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sichuan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Li Zheng
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Li Zheng
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
West China of Sichuan University
Chengdu, Sichuan, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Iris Li
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ATG-008-HX-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.