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NCT03591965
Dual TORC1/TORC2 Inhibitor ATG-008 (CC-223) in HBV Positive Advanced Hepatocellular Carcinoma (HCC) Subjects
Phase 2 trial testing ATG-008 in Hepatocellular Carcinoma in 73 participants. Terminated before completion.
3 August 2022
Quick facts
| Lead sponsor | Antengene Therapeutics Limited |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 73 |
| Start date | 7 August 2018 |
| Primary completion | 3 August 2022 |
| Estimated completion | 3 August 2022 |
| Sites | 30 locations across China, Taiwan, South Korea |
Drugs / interventions tested
- ATG-008 — full drug profile →
Conditions studied
- Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
Sponsor
Antengene Therapeutics Limited — full company profile →
Who can join
Adults 18 to 70, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is an Asian multi-regional clinical trial (MRCT) in which ATG-008 will be administered orally to hepatitis B positive (HBV+) HCC subjects who have received at least one prior line of systemic therapy. It is designed as an open-label phase 2 trial evaluating the pharmacokinetics (PK), safety, tolerability and efficacy of oral ATG-008 administered daily until the radiologic disease progression (according to RECIST 1.1) or intolerable toxicity.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Multifaceted role of mTOR (mammalian target of rapamycin) signaling pathway in human health and disease.
Panwar V, Singh A, Bhatt M, Tonk RK, et al · · 2023 · cited 628× · PMID 37779156 · DOI 10.1038/s41392-023-01608-z -
Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2 -
Molecular pathogenesis and systemic therapies for hepatocellular carcinoma.
Llovet JM, Pinyol R, Kelley RK, El-Khoueiry A, et al · · 2022 · cited 365× · PMID 35484418 · DOI 10.1038/s43018-022-00357-2 -
Targeting the PI3K/Akt/mTOR Pathway in Hepatocellular Carcinoma.
Sun EJ, Wankell M, Palamuthusingam P, McFarlane C, et al · · 2021 · cited 199× · PMID 34829868 · DOI 10.3390/biomedicines9111639 -
The Role of PI3K/AKT/mTOR Signaling in Hepatocellular Carcinoma Metabolism.
Tian LY, Smit DJ, Jücker M. · · 2023 · cited 193× · PMID 36768977 · DOI 10.3390/ijms24032652 -
Advances in drug development for hepatocellular carcinoma: clinical trials and potential therapeutic targets.
Luo XY, Wu KM, He XX. · · 2021 · cited 144× · PMID 34006331 · DOI 10.1186/s13046-021-01968-w -
Hepatocellular carcinoma: signaling pathways and therapeutic advances.
Zheng J, Wang S, Xia L, Sun Z, et al · · 2025 · cited 142× · PMID 39915447 · DOI 10.1038/s41392-024-02075-w -
The mTORC2-Akt1 Cascade Is Crucial for c-Myc to Promote Hepatocarcinogenesis in Mice and Humans.
Xu Z, Xu M, Liu P, Zhang S, et al · · 2019 · cited 83× · PMID 31062368 · DOI 10.1002/hep.30697
Verify or expand the search:
- PubMed search for NCT03591965
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ATG-008
Trials testing the same drug.
- NCT04998760 — A Study to Evaluate Dual mTORC1/2 Inhibitor (ATG 008) or Selective Inhibitor of Nuclear Export Compound (ATG-010) in Com · Phase 2 · unknown
- NCT04337463 — ATG-008 Combined With Toripalimab in Advanced Solid Tumors · Phase 1, PHASE2 · unknown
Other recruiting trials for Hepatocellular Carcinoma
Currently open trials in the same condition.
- NCT06902246 — Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma · Phase 2 · recruiting
- NCT05842174 — Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma · Phase 1, PHASE2 · recruiting
- NCT07417397 — Adjuvant TACE in HCC With High-risk Recurrence Factors · Phase 3 · recruiting
- NCT07317414 — β-alanine in the Treatment of Advanced Hepatocellular Carcinoma · Phase 2 · recruiting
- NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer · Phase 1 · recruiting
Other Antengene Therapeutics Limited trials
Trials by the same sponsor.
- NCT05205109 — A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Co · Phase 1 · recruiting
- NCT04305249 — Safety and Preliminary Efficacy of ATG-017 Monotherapy or Combination Therapy With Nivolumab in Advanced Solid Tumors an · Phase 1 · terminated
- NCT04281420 — A Study of Evaluating Dual Inhibitor of PAK4 and NAMPT ATG-019 in Advanced Solid Tumors or Non-Hodgkin's Lymphoma · Phase 1 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03591965 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Antengene Therapeutics Limited
- Last refreshed: 10 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03591965.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing