Clinical trial · Interventional
ATG-008 Combined With Toripalimab in Advanced Solid Tumors
An Open, Dose-escalation and Expansion Study With a Dual TORC1/2 Inhibitor of ATG-008 Combined With PD-1 Antibody of Toripalimab in Advanced Solid Tumors
NCT04337463CI-TRIAL-00051841unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ATG-008 | Drug | Onatasertib | ALIAS |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ATG-008 and Toripalimab
- description
- Toripalimab will be combined with ATG-008.
- interventionNames
- Drug: ATG-008
- Drug: Toripalimab
Primary outcomes (3)
- measure
- MTD
- timeFrame
- Within 21 days after dosing
- description
- Maximum Tolerated Dose
- measure
- RP2D
- timeFrame
- Within 21 days after dosing
- description
- Recommended phase 2 dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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%.
References
Publications (1)
- DERIVEDShu P, Li X, Zhou Q, Li G, Zhang K, Yuan L, Liu Y, Li Q, Wang Y, Xie H, Zheng L. Multicenter phase 1/2 study of onatasertib, a dual TORC1/2 inhibitor, combined with the PD-1 antibody toripalimab in advanced solid tumors. Signal Transduct Target Ther. 2025 Jun 25;10(1):198. doi: 10.1038/s41392-025-02281-0. PMID 40555721