Informations générales (source: ClinicalTrials.gov)
A Phase I/II, Open-label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-drug Conjugate) as a Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
Interventional
Phase 1/Phase 2
Alentis Therapeutics AG (Voir sur ClinicalTrials)
août 2025
octobre 2029
03 mai 2026
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic,
pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase
II dose (RP2D) of the ALE.P03 monotherapy in adult patients with selected squamous solid
tumors.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Antoine HOLLEBECQUE | 17/06/2026 06:20:06 | Contacter | ||
Critères
Tous
- Have histologically and cytologically metastatic confirmed advanced or metastatic
colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung
cancer, urothelial carcinoma, and cervical squamous cell carcinoma.
- Have documented radiological disease progression at study entry.
- Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory.
Phase I Dose Escalation:
- Received and being refractory/intolerant to available systemic standard of care (SOC)
regimens (based on local institutional guidelines) for advanced disease.
Phase I RDE and Phase II:
- Received 1-2 available systemic SOC regimens (based on local institutional
guidelines) for advanced disease and being refractory or intolerant to treatment.
- Patients with actionable oncogenic drivers: received feasible targeted therapy.
Applicable for Phase I Dose Escalation, Phase I RDE and Phase II:
- Measurable disease per RECIST 1.1, as determined by the site.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups
Performance Status.
- Demonstrate adequate bone marrow and organ function as per the protocol.
Exclusion Criteria:
- SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology
result or adenocarcinoma.
- Has received antineoplastic therapies prior to study intervention within specified
time frame.
- Has rapidly progressing disease.
- Has known active central nervous system metastases and/or carcinomatous meningitis.
- Has a history of (non-infectious) interstitial lung disease/pneumonitis that
required steroids or current symptomatic or clinically significant pneumonitis
requiring steroids and/or immunosuppressive therapies.
- Has clinically significant gastrointestinal bleeding.
- Has an active infection requiring systemic treatment.
- Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the clinical study.