Drugs / TK216
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT03752138 | Mar 2019 → Dec 2020 | acute myeloid leukemia | M.D. Anderson Cancer Center | Withdrawn | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02657005 | Aug 2016 → May 2022 | Ewing sarcoma | Oncternal Therapeutics, Inc | Terminated | No outcome recorded Stop: Business |
| Phase 21 trial | ||||||
| Phase 2 | NCT05046314 | Mar 2024 → Feb 2025 | Ewing sarcoma | Shanghai Pharmaceuticals Holding Co., Ltd | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2021-04-28 | SPH-BIOCAD (HK) Limited | Regulatory SPH8216(TK216) 注射液获得临床试验Ⅱ期批准通知书 sphchina.com ↗
近日，该项目获得国家药监局核准签发《药物临床试验批准通知书》，同意按照已提交的方案开展TK216 在中国复发或难治性尤文肉瘤患者中的有效性和安全性的 II 期临床试验。 |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2021-04-28 | SPH-BIOCAD (HK) Limited | SPH8216(TK216) 注射液获得临床试验Ⅱ期批准通知书 sphchina.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TK216 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03752138 ↗ |
| Known as | Tokalas | “Tokalas (TK)216 was designed to bind EWS::FLI1 proteins directly, disrupt protein-protein interactions, and inhibit transcription factor function.” PMID 38954782 ↗ Jul 2024 |
| Action | Inhibit | “Tokalas (TK)216 was designed to bind EWS::FLI1 proteins directly, disrupt protein-protein interactions, and inhibit transcription factor function.” PMID 38954782 ↗ Jul 2024 |
| Route | Intravenous | “TK216 was administered intravenously as a continuous infusion to patients with R/R ES in 11 cohorts.” PMID 38954782 ↗ Jul 2024 |
| Target | FLI1 | “Tokalas (TK)216 was designed to bind EWS::FLI1 proteins directly, disrupt protein-protein interactions, and inhibit transcription factor function.” PMID 38954782 ↗ Jul 2024 |