Drugs / ONATASERTIB
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT05354362 | Mar 2022 → Feb 2023 | relapsed/refractory diffuse large B-cell lymphoma | Antengene Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02031419 | Dec 2013 → Dec 2023 | diffuse large B-cell lymphoma | Celgene Corporation | Terminated | No outcome recorded |
| Phase 1 | NCT01896323 | Jul → Aug 2013 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01611467 | Jun → Jul 2012 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01545947 | May 2012 → Dec 2014 | non-small cell lung carcinoma | Celgene Corporation | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04337463 | Apr 2020 → May 2022 | neoplasm | Sichuan University | Unknown | No outcome recorded |
| Phase 1/2 | NCT01177397 | Jul 2010 → Nov 2016 | diffuse large B-cell lymphoma, glioblastoma, hepatocellular carcinoma, hormone receptor-positive breast cancer +3 | Celgene Corporation | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04998760 | Aug 2021 → Jan 2024 | endometrial cancer, ovarian cancer | Qi Zhou | Unknown | No outcome recorded |
| Phase 2 | NCT04518137 | Apr 2021 → May 2022 | cancer | Antengene Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03591965 | Aug 2018 → Aug 2022 | hepatocellular carcinoma | Antengene Therapeutics Limited | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2025-05-23 | Antengene Corporation | Results Antengene to Present Latest Clinical Results from Two Studies in CPI-resistant Solid Tumors at ASCO 2025 antengene.com ↗
ATG-008, an oral dual mTORC1/2 inhibitor, in combination with toripalimab, achieved an ORR of 22.2% and DCR of 85.2% in CPI-resistant cervical cancer patients in the ongoing TORCH-2 trial. |
| 2024-05-24 | Antengene Corporation | Results Antengene To Present One Oral and Four Abstracts at ASCO 2024 antengene.com ↗
ATG-008 (Onatasertib; oral TORC1/2 inhibitor) combined with toripalimab (anti-PD-1 antibody) showed promising anti-tumor activity and accep |
| 2023-11-17 | Antengene Corporation | Results Antengene Presents Encouraging Clinical Data from Four Pipeline Programs at the 2023 R&D Day antengene.com ↗
ATG-008 (dual mTORC1/2 inhibitor) continued showing strong clinical activities in the Phase II program, with promising efficacy data in cervical cancer patients compared to benchmarks. |
| 2023-08-25 | Antengene Corporation | Results Antengene Announces Interim Financial Results for 2023 with New Clinical Data Highlighting the Growing Value of Its Pipeline antengene.com ↗
Based on the latest data review as of August 23rd, 2023, out of the 31 CPI-naïve patients who received treatment (and 28 who had at least one tumor assessment), the objective response rate (ORR) was observed to be 46.4%. |
| 2023-05-26 | Antengene Corporation | Results Antengene To Present Latest Results from TORCH-2 Study of ATG-008 in Advanced Solid Tumors in Poster Discussion at ASCO 2023 antengene.com ↗
The combination treatment produced an objective response rate (ORR ) of 52.4% in the advanced cervical cancer cohort |
| 2023-04-18 | Antengene Corporation | Results Antengene Announces Five Presentations at the 2023 American Association for Cancer Research Meeting antengene.com ↗
Clinical results showed promising efficacy of ATG-008 in patients with advanced HBV+ HCC, especially those who had received CPIs |
| 2022-11-15 | Antengene Corporation | Results Antengene Highlights Encouraging ATG-008 Efficacy Results From TORCH-2 Study in Combination with PD-1 Antibody in Relapsed/Metastatic Cervical Cancer antengene.com ↗
The combination therapy demonstrated an ORR of 52.4% (based on all treated patients) regardless of PD-L1 status. |
| 2022-06-01 | Antengene Corporation | Results Antengene to Present Clinical Results of ATG-008 (Onatasertib) at the 2022 American Society of Clinical Oncology Annual Meeting antengene.com ↗
As of the data cut-off on December 20, 2021, the overall response rate (ORR) was 28.6% (based on 6 patients with 5 confirmed responses) and the disease control rate (DCR) was 71.4%. |
| 2021-11-19 | Antengene Corporation | Results Treating Patients Beyond Borders - Antengene Successfully Hosted Its First R&D Day antengene.com ↗
New data from 20 efficacy evaluable patients showed 1 CR, 5 PR (ORR = 30%), 9 SD (DCR = 75%). |
| 2021-11-02 | Antengene Corporation | Regulatory Antengene Granted IND Approval in China for the Phase Ib Study of ATG-008 (Onatasertib) in Combination with ATG-010 (Selinexor) in Patients with Diffuse Large B-Cell Lymphoma antengene.com ↗
Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that China’s National Medical Products Administration (NMPA) has approved an open-label Phase Ib dose-escalation study designed to assess the safety of ATG-008 (onatasertib) in combination with ATG-010 (selinexor) in patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). |
| 2021-04-12 | Antengene Corporation | Results Antengene Presented Preclinical Data Demonstrating Potent Synergistic Effect of the Combination of ATG-010 (Selinexor) and ATG-008 (Onatasertib) for the Treatment of Triple-Hit DLBCL antengene.com ↗
Results from this study demonstrated potent in vitro and in vivo anti-tumor efficacy and synergy with the combination of ATG-010 and ATG-008, including strong synergistic activities in the triple-hit DLBCL cell line. |
| 2020-08-24 | Antengene Corporation | Regulatory Antengene Announces IND Approval by NMPA to Initiate a Phase II Clinical Trial of ATG-008 for the Treatment of Advanced Solid Tumors with Specific Genetic Alterations antengene.com ↗
the National Medical Products Administration (NMPA) has approved a phase II trial of ATG-008 for the treatment of patients with advanced solid tumors harboring NFE2L2, STK11, RICTOR or other specific genetic alterations. |
| 2018-06-22 | Antengene Corporation | Regulatory Antengene obtaining Korean IND approval for ATG-008, a mTOR Kinase Dual-Targeted Inhibitor antengene.com ↗
On June 22, 2018, Antengene announced that ATG-008, its innovative drug for the treatment of advanced hepatocellular carcinoma (HCC), has successfully passed the review of investigational new drug (IND) application by South Korean Ministry of Food and Drug Safety (MFDS). |
| 2018-06-13 | Antengene Corporation | Regulatory ATG-008, China’s first TORC1/2 dual-targeted inhibitor of the new generation, has obtained IND approval antengene.com ↗
On June 13, 2018, Antengene Corporation announced that ATG-008, a new Category I drug developed by the company for the treatment of advanced hepatocellular carcinoma (HCC), is successfully approved by the National Medical Products Administration. |
| 2018-03-26 | Antengene Corporation | Regulatory Antengene Corporation Announces TFDA Approval of IND Application for a Phase II Study of ATG-008, a Next Generation mTOR Inhibitor, in Patients with Late-stage Hepatocellular Carcinoma (HCC) antengene.com ↗
The currently approved trial is the first program of ATG-008 that aims to study the safety and efficacy of the dual TORC1/2 inhibitor in patients with late-stage HCC. |
| 2018-02-07 | Antengene Corporation | Regulatory Antengene Corporation has submitted The Phase 2 Clinical Trial Application of ATG-008 to China, Taiwan and Korea antengene.com ↗
Antengene Corporation has submitted The Phase 2 Clinical Trial Application of ATG-008 to China, Taiwan and Korea. |
All press releases naming this drug 27 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 11 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ONATASERTIB | ChEMBL registry synonym — accepted as the source's own label CHEMBL3586404 ↗ |
| Known as | ATG-008 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04998760 ↗ |
| Known as | CC-223 | “Dual TORC1/TORC2 Inhibitor ATG-008 (CC-223) in HBV Positive Advanced Hepatocellular Carcinoma (HCC) Subjects” NCT03591965 ↗ |
| Action | Inhibit | “mTOR Kinase Inhibitor CC-223” NCT01177397 ↗ |
| Modality | Small molecule | — CHEMBL3586404 ↗ |
| Route | Oral | “CC-223 Administered Orally” NCT01177397 ↗ |
| Target | MTOR | “mTOR Kinase Inhibitor CC-223” NCT01177397 ↗ |