Drugs / HLX301
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05390528 | Jun 2022 → Sep 2023 | lymphoma, metastatic neoplasm | Shanghai Henlius Biotech | Unknown | No outcome recorded |
| Phase 1/2 | NCT05102214 | May 2022 → Sep 2023 | non-small cell lung carcinoma | Shanghai Henlius Biotech | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2022-03-18 | Shanghai Henlius Biotech | Regulatory Henlius’ Potential First-in-Class Anti-PD-L1×TIGIT Bispecific Antibody HLX301 IND Approved by NMPA henlius.com ↗
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the filing of a Phase 1 clinical trial for HLX301, a Recombinant Humanized Anti-PDL1 and Anti-TIGIT Bispecific Antibody (BsAb), in Patients with advanced tumours has been approved by the National Medical Products Administration (NMPA). |
| 2021-11-24 | Shanghai Henlius Biotech | Regulatory Henlius Novel Anti PD-L1/TIGIT Bispecific Antibody Received Clinical Trial Approval in Australia henlius.com ↗
Clinical Trial Notification (“CTN”) has been acknowledged by the Therapeutic Goods Administration (“TGA”), Australia. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-03-18 | Shanghai Henlius Biotech | Henlius’ Potential First-in-Class Anti-PD-L1×TIGIT Bispecific Antibody HLX301 IND Approved by NMPA henlius.com ↗ |
| 2021-11-24 | Shanghai Henlius Biotech | Henlius Novel Anti PD-L1/TIGIT Bispecific Antibody Received Clinical Trial Approval in Australia henlius.com ↗ |
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 | HLX301 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05390528 ↗ |
| Route | Intravenous | “administered as a single intravenous (IV) infusion” NCT05102214 ↗ |
| Target | TIGIT | “Anti-PDL1 and Anti-TIGIT” NCT05102214 ↗ |