Trials / Recruiting
RecruitingNCT06747585
A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors
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 CLDN1+Squamous Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 170 (estimated)
- Sponsor
- Alentis Therapeutics AG · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.P02 monotherapy in adult patients with selected squamous solid tumors.
Detailed description
This Study has a Phase I ALE.P02 monotherapy dose escalation and recommended dose for expansion (RDE) study and a Phase II study of ALE.P02 as monotherapy at RP2D in adult patients with selected advanced or metastatic Claudin-1 positive (CLDN1+) cancers.
Conditions
- Squamous Non-small-cell Lung Cancer
- Head and Neck Squamous Cell Carcinoma
- Cervical Squamous Cell Carcinoma
- Esophageal Squamous Cell Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALE.P02 | ALE.P02, will be administered by IV infusion according to the assigned arms. |
Timeline
- Start date
- 2024-12-16
- Primary completion
- 2028-02-15
- Completion
- 2028-08-15
- First posted
- 2024-12-24
- Last updated
- 2026-03-03
Locations
38 sites across 8 countries: United States, France, Hong Kong, Italy, Singapore, South Korea, Spain, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06747585. Inclusion in this directory is not an endorsement.