Drugs / ALE.P02
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT06747585 | Dec 2024 → Feb 2028 expected | cervical squamous cell carcinoma, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, non-small cell squamous lung carcinoma | Alentis Therapeutics AG | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-11-18 | Alentis Therapeutics AG | Regulatory Alentis Receives FDA Fast Track Designation for ALE.P02 for the Treatment of CLDN1+ Squamous Solid Tumors alentis.ch ↗
Alentis Therapeutics (“Alentis”), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ALE.P02 for the treatment of advanced or metastatic CLDN1+ squamous cancers irrespective of the organ of origin. |
| 2024-10-02 | Alentis Therapeutics AG | Regulatory Alentis Therapeutics Receives FDA IND Clearance for ALE.P02, a Novel CLDN1-ADC for the Treatment of Squamous Cancers alentis.ch ↗
Alentis Therapeutics (“Alentis”), the clinical-stage biotechnology company developing treatments for Claudin-1 positive (CLDN1+) tumors and organ fibrosis, announced today that the U.S. Food & Drug Administration (FDA) cleared an IND application for ALE.P02, an anti-CLDN1 ADC with a tubulin inhibitor payload. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-11-18 | Alentis Therapeutics AG | Alentis Receives FDA Fast Track Designation for ALE.P02 for the Treatment of CLDN1+ Squamous Solid Tumors alentis.ch ↗ |
| 2024-10-02 | Alentis Therapeutics AG | Alentis Therapeutics Receives FDA IND Clearance for ALE.P02, a Novel CLDN1-ADC for the Treatment of Squamous Cancers alentis.ch ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ALE.P02 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06747585 ↗ |
| Route | Intravenous | “via intravenous infusion” NCT06747585 ↗ |
| Target | CLDN1 | “A Phase I/II, Open-Label, Multicenter Study of ALE.P02 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic...” NCT06747585 ↗ |