Drugs / APG-1387
APG-1387
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03585322 | Jul 2018 → Oct 2021 | chronic hepatitis B virus infection | Ascentage Pharma Group Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03386526 | Nov 2017 → Oct 2022 | neoplasm | Ascentage Pharma Group Inc. | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04643405 | Mar 2021 → Jun 2024 | pancreatic adenocarcinoma | Ascentage Pharma Group Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04284488 | Apr 2020 → Nov 2024 | neoplasm | Ascentage Pharma Group Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 21 trial | ||||||
| Phase 2 | NCT04568265 | Jun 2020 → Oct 2022 | chronic hepatitis B virus infection | Ascentage Pharma Group Inc. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2022-11-07 | Ascentage Pharma Group Inc. | Results AASLD 2022 | Ascentage Pharma Releases Phase I Results of IAP Antagonist APG-1387 in an Oral Report Showing Potential for Functionally Curing CHB ascentage.com ↗
Ascentage Pharma (6855.HK) today announced that it has released results from a Phase I study of the investigational inhibitor of apoptosis protein (IAP) antagonist APG-1387 in Chinese patients with chronic hepatitis B (CHB), in an oral presentation at the 73rd American Association for the Study of Liver Diseases Annual Meeting (AASLD 2022). |
| 2022-10-20 | Ascentage Pharma Group Inc. | Results AASLD 2022 | Ascentage Pharma to Announce Results from First-in-Human Study of IAP Antagonist APG-1387 in an Oral Report at the AASLD Annual Meeting ascentage.com ↗
This presentation will mark the first data readout reporting favorable safety and preliminary efficacy of an IAP antagonist for the treatment of CHB |
| 2021-04-12 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Releases Preclinical Data of Its Core Drug Candidates at AACR Annual Meeting 2021, with Results Signifying the Potential of Multiple Combination Therapies in Cancer ascentage.com ↗
Therapeutic potential of inhibitor of apoptosis protein (IAP) inhibitor APG-1387 combined with DR5 agonist monoclonal antibody (mAb) CTB-006 in preclinical models of solid tumors |
| 2021-03-10 | Ascentage Pharma Group Inc. | Results Ascentage Pharma to Present the Latest Results from Six Preclinical Studies at AACR Annual Meeting 2021 ascentage.com ↗
Therapeutic potential of inhibitor of apoptosis protein (IAP) inhibitor APG-1387 combined with DR5 agonist monoclonal antibody (mAb) CTB-006 in preclinical models of solid tumors |
| 2020-08-27 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Releases Preclinical Results of IAP Antagonist APG-1387 in an Oral Presentations at EASL ILC 2020 ascentage.com ↗ |
| 2020-05-31 | Ascentage Pharma Group Inc. | Results (ASCO2020) Ascentage Pharma Presents Latest Clinical Data of Apoptosis Targeting Drug Candidates, Showing Promising Clinical Effects with Combination Therapies ascentage.com ↗
In this Phase Ib study, the novel IAP antagonist APG-1387 was combined safely with pembrolizumab with a manageable adverse event profile. |
| 2020-02-24 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces Approval for the Phase Ib/II Clinical Trial of APG-1387 in Combination with Chemotherapy for the Treatment of Advanced Pancreatic Cancer in China ascentage.com ↗ |
| 2019-05-23 | Ascentage Pharma Group Inc. | Results Ascentage Pharma to Present New Data at 2019 ASCO Annual Meeting from Clinical Trials of MDM2-p53 Antagonist and IAP Inhibitor in Cancers ascentage.com ↗
APG-1387 was well tolerated and had manageable adverse events. |
| 2018-05-21 | Ascentage Pharma Group Inc. | Results Ascentage Pharma Announces Promising Phase 1 Interim Results in Two Clinical Programs to Be Presented at 2018 ASCO Annual Meeting ascentage.com ↗
Preliminary results showed that APG-1252 was well-tolerated with no hematologic toxicity reported. |
| 2018-01-08 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces Acceptance of IND Application by China FDA for Clinical Study of Novel IAP Inhibitor to Treat Hepatitis B Infection ascentage.com ↗
the China Food and Drug Administration (CFDA) has accepted the Investigational New Drug (IND) application for APG-1387 |
| 2017-11-15 | Ascentage Pharma Group Inc. | Regulatory Ascentage Pharma Announces U.S. FDA Acceptance of IND Application for Clinical Study of Novel IAP Inhibitor APG-1387 to Treat Advanced Solid Tumors and Blood Cancers ascentage.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for APG-1387, a novel small molecule IAP inhibitor for the treatment of advanced solid tumors and hematologic malignancies. |
All press releases naming this drug 16 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | APG-1387 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04643405 ↗ |
| Known as | APG-1387 (SMAC MIMETIC) | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594459 ↗ |
| Known as | SM-1387 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594459 ↗ |
| Action | Inhibit | “APG-1387 is a novel second mitochondria-derived activator of caspase (Smac) mimetic IAP inhibitor.” PMID 38790057 ↗ May 2024 |
| Modality | Small molecule | “APG-1387 is a potent, bivalent small-molecule Inhibitor of Apoptosis Protein (IAP) antagonist.” NCT03386526 ↗ |
| Route | Intravenous | “30 minute IV infusion” NCT03386526 ↗ |