Drugs / ALMB-0168
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04886765 | May 2021 → Nov 2023 | osteosarcoma | AlaMab Therapeutics (Shanghai) Inc. | Unknown | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06416358 | May 2024 → Jun 2026 overdue | cancer | AlaMab Therapeutics (Shanghai) Inc. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2020-09-15 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - INVESTIGATIONAL NEW DRUG "ALMB-0168" OBTAINS CLINICAL TRIAL APPROVAL IN CHINA irasia.com ↗
The board of directors (the “ Board”) of CSPC Pharmaceutical Group Limited (the “ Company ”, together with its subsidiaries, the “Group”) is pleased to announce that AlaMab Therapeutics (Shanghai) Inc.*ʮ ̡ , a subsidiary of the Company, has obtained approval from the National Medical Products Administration of the People’s Republic of China for conducting clinical trial of the investigational new drug ALMB-0168 for the treatment of bone cancer and bone metastasis in China. |
| 2020-02-24 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - INVESTIGATIONAL NEW DRUG ALMB-0168 WAS GRANTED CLINICAL TRIAL APPROVAL IN AUSTRALIA irasia.com ↗
The board of directors (the “ Board”) of CSPC Pharmaceutical Group Limited (the “ Company ”, together with its subsidiaries, the “ Group”) is pleased to announce that AlaMab Therapeutics Inc. (“AlaMab”), a subsidiary of the Company, has obtained approval from the relevant Ethics Committee and Clinical Trial Centre, and received the Acknowledgement of Clinical Trial Notification from the government regulatory body, Therapeutic Goods Administration, for conducting the first-in-human clinical trial of its investigational new drug ALMB-0168 for the treatment of bone cancer and cancer bone metastasis in Australia. |
| 2020-02-24 | AlaMab Therapeutics (Shanghai) Inc. | Regulatory Clinical Trial Approval in Australia alamab.com ↗
INVESTIGATIONAL NEW DRUG ALMB-0168 GRANTED CLINICAL TRIAL APPROVAL IN AUSTRALIA |
| 2019-11-27 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - SUBMISSION OF CLINICAL TRIAL APPLICATION FOR INVESTIGATIONAL FIRST-IN-CLASS NEW DRUG ALMB-0168 IN AUSTRALIA irasia.com ↗
The Board of Directors (the “ Board”) of CSPC Pharmaceutical Group Limited (the “ Company ”, together with its subsidiaries, the “Group”) is pleased to announce that AlaMab Therapeutics Inc. (“a lamab ”), a subsidiary of the Company, has submitted a clinical trial application to the relevant Ethics Committee in Australia for the first-in-human study for its investigational new drug, humanized monoclonal antibody agonist for hemichannel connexin 43 (Cx43) (ALMB-0168). |
| 2019-11-27 | AlaMab Therapeutics (Shanghai) Inc. | Regulatory Submission of Clinical Trial Application in Australia alamab.com ↗
AlaMab Therapeutics Inc. (“AlaMab”), a subsidiary of the Company, has submitted a clinical trial application to the relevant Ethics Committee in Australia for the first-in-human study for its investigational new drug, humanized monoclonal antibody agonist for hemichannel connexin 43 (Cx43) (ALMB-0168). |
| 2019-10-18 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - FIRST-IN-CLASS PRODUCT CANDIDATE ALMB-0168 GRANTED RARE PEDIATRIC DISEASE DESIGNATION BY THE U.S. FDA irasia.com ↗
FIRST-IN-CLASS PRODUCT CANDIDATE ALMB-0168 GRANTED RARE PEDIATRIC DISEASE DESIGNATION BY THE U.S. FDA |
| 2019-10-18 | AlaMab Therapeutics (Shanghai) Inc. | Regulatory ALMB-0168 Granted Rare Pediatric Disease Designation alamab.com ↗
It represents another designation of ALMB-0168 in addition to the orphan-drug designation granted by the U.S. FDA in September 2019. |
| 2019-09-23 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory FIRST-IN-CLASS PRODUCT CANDIDATE ALMB-0168 WAS GRANTED ORPHAN-DRUG DESIGNATION BY THE U.S. FDA irasia.com ↗ |
| 2019-09-23 | AlaMab Therapeutics (Shanghai) Inc. | Regulatory FIRST-IN-CLASS PRODUCT CANDIDATE ALMB-0168 alamab.com ↗
This orphan-drug designation will allow the Group to communicate with the FDA frequently and speed up the clinical development, registration and launch of ALMB-0168. |
All press releases naming this drug 11 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ALMB-0168 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04886765 ↗ |
| Action | Activate | “ALMB-0168 is designed to activate Cx43 hemichannels” NCT06416358 ↗ |
| Route | Intravenous | “ALMB-0168 will be administered intravenously until either the disease progresses or intolerable toxicity occurs.” NCT04886765 ↗ |