Drugs / HLX42
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06210815 | Mar 2024 → Sep 2026 overdue | non-small cell lung carcinoma | Shanghai Henlius Biotech | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2023-12-27 | Shanghai Henlius Biotech | Regulatory FDA Grants Fast Track Designation to Henlius’ EGFR-Targeting ADC HLX42 for NSCLC Patients with Disease Progression on EGFR Targeted Therapies henlius.com ↗ |
| 2023-11-23 | Shanghai Henlius Biotech | Regulatory Henlius Receives the FDA IND Approval for Its EGFR-Targeting ADC Candidate HLX42 henlius.com ↗
This is the first overseas IND approval that HLX42 has received, after being approved for clinical trial by the National Medical Products Administration (NMPA). |
| 2023-10-27 | Shanghai Henlius Biotech | Regulatory Henlius Announces NMPA Approvals of Two ADC Candidates for IND henlius.com ↗ |
| 2023-10-24 | Shanghai Henlius Biotech | Results Results From the Preclinical Study of HLX42, a Potential BIC EGFR-Targeting ADC Released at 2023 ESMO henlius.com ↗ |
All press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-03-15 | Shanghai Henlius Biotech | First Subject Dosed for Phase 1 Clinical Trial of Henlius’ ADC Candidate HLX42 henlius.com ↗ |
| 2024-01-02 | Shanghai Henlius Biotech | Expanded Access Policy for HLX42 henlius.com ↗ |
| 2023-12-27 | Shanghai Henlius Biotech | FDA Grants Fast Track Designation to Henlius’ EGFR-Targeting ADC HLX42 for NSCLC Patients with Disease Progression on EGFR Targeted Therapies henlius.com ↗ |
| 2023-11-23 | Shanghai Henlius Biotech | Henlius Receives the FDA IND Approval for Its EGFR-Targeting ADC Candidate HLX42 henlius.com ↗ |
| 2023-10-27 | Shanghai Henlius Biotech | Henlius Announces NMPA Approvals of Two ADC Candidates for IND henlius.com ↗ |
| 2023-10-24 | Shanghai Henlius Biotech | Results From the Preclinical Study of HLX42, a Potential BIC EGFR-Targeting ADC Released at 2023 ESMO henlius.com ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX42 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06210815 ↗ |
| Modality | Monoclonal antibody | “anti-EGFR monoclonal antibody” NCT06210815 ↗ |
| Route | Intravenous | “via intravenous infusion” NCT06210815 ↗ |
| Target | EGFR | “anti-EGFR monoclonal antibody” NCT06210815 ↗ |