Drugs / HLX208
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT05902728 | Jul → Dec 2023 | non-small cell lung carcinoma | Shanghai Henlius Biotech | Completed | No outcome recorded |
| Phase 1 | NCT05841940 | Jun → Jul 2023 | — | Shanghai Henlius Biotech | Completed | No outcome recorded |
| Phase 1 | NCT04965220 | Jan 2022 → Jun 2024 | cancer | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05641493 | Feb 2023 → Mar 2025 | non-small cell lung carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 1/2 | NCT05102292 | Dec 2021 → Jun 2024 | thyroid gland undifferentiated (anaplastic) carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 27 trials | ||||||
| Phase 2 | NCT05528406 | Oct 2022 → Oct 2024 | cancer | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT05127759 | Mar 2022 → Jan 2024 | colorectal cancer | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT05114603 | Mar 2022 → Aug 2023 | melanoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT05092802 | Dec 2021 → May 2023 | primary brain neoplasm | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT05092815 | Dec 2021 → Jun 2024 | Erdheim-Chester disease, Langerhans cell histiocytosis | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT05065398 | Nov 2021 → Jun 2023 | non-small cell lung carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 2 | NCT04984369 | Aug 2021 → Jun 2024 | — | Shanghai Henlius Biotech | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2023-12-04 | Shanghai Henlius Biotech | Results Results from the Phase 2 Clinical Trial of Henlius BRAF Inhibitor HLX208 for the Treatment of LCH and/or ECD Released at 2023 ESMO Asia henlius.com ↗
Recently, results from the phase 2 study (HLX208-LCH/ECD201) of Henlius' innovative BRAFV600E inhibitor, HLX208, in adult Langerhans cell histiocytosis (LCH) and Erdheim-Chester disease (ECD) with BRAFV600E mutation were released in the form of mini oral presentation at European Society for Medical Oncology Asia (ESMO Asia) Congress 2023. |
| 2023-06-06 | Shanghai Henlius Biotech | Results Results From the Phase 2 Clinical Trial of Henlius BRAFV600E Inhibitor HLX208 for the Treatment of LCH and/or ECD Released at 2023 ASCO Annual Meeting henlius.com ↗ |
| 2023-04-06 | Shanghai Henlius Biotech | Regulatory CDE Grants Breakthrough Therapy Designation to Henlius BRAF Inhibitor HLX208 henlius.com ↗ |
| 2022-11-11 | Shanghai Henlius Biotech | Regulatory The IND Application of Phase 1b/2 Clinical Trial of BARF V600E Inhibitor HLX208 in Combination with HANSIZHUANG for the Treatment of BARF V600 Mutation-Positive Solid Tumours was Approved by the NMPA henlius.com ↗
for the treatment of BRAF V600E or BRAF V600 mutation-positive advanced solid tumours was approved by the National Medical Products Administration (NMPA). |
| 2022-01-18 | Shanghai Henlius Biotech | Regulatory Accelerating the Innovation Pipeline, Henlius BRAF Inhibitor HLX208 IND for Phase 1b/2 Studies Approved by NMPA henlius.com ↗
Shanghai, China, January 18th, 2022 - Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the National Medical Products Administration (NMPA) has approved HLX208, a small-molecule inhibitor the company licensed from NeuPharma, to be investigated in Phase 1b/2 clinical trials as monotherapy or in combination therapy for the treatment of BRAF V600E or BRAF V600 mutation-positive advanced solid tumours. |
All press releases naming this drug 6 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX208 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05092802 ↗ |
| Action | Inhibit | “BRAF V600E Inhibitor” NCT04965220 ↗ |
| Route | Oral | “take orally” NCT04965220 ↗ |
| Target | BRAF | “BRAF V600E Inhibitor” NCT04965220 ↗ |