A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Alentis Therapeutics AG
Study ID
NCT06747585
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ALE.P02 — DRUG
    ALE.P02, will be administered by IV infusion according to the assigned arms.

Study Details

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.

Key Dates

Start date
Dec 16, 2024
Status verified
Mar 2026
Primary completion
Feb 15, 2028
Completion
Aug 15, 2028

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Dose Escalation- ALE.P02
    Patients will receive ALE.P02 as monotherapy via intravenous infusion. The ALE.P02 will be given at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose for Expansion (RDE) is determined in Phase I dose escalation part of the study.
  • Experimental: Phase I Dose Expansion- ALE.P02
    Patients will receive ALE.P02 as monotherapy via intravenous infusion. The safe recommended dose of ALE.P02 will be given in Phase I dose expansion part of the study to identify Recommended Phase II Dose (RP2D) for Phase II.
  • Experimental: Phase II- ALE.P02
    Patients will receive ALE.P02 as monotherapy via intravenous infusion at the RP2D, or according to the dosing schedule after the dose expansion phase.

Primary Outcome Measure

Number of Patients with Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Mayo Foundation for Medical Education and Research - Mayo ClScottsdaleArizona85259-
Providence Medical FoundationFullertonCalifornia92835-
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
Yale Comprehensive Cancer CenterNew HavenConnecticut06510-
The University of Chicago Medical Center - OncologyChicagoIllinois60637-
Norton Cancer Institue DowntownLouisvilleKentucky40202-
Hackensack University Medical CenterHackensackNew Jersey07601-
NEXT Oncology VirginiaFairfaxVirginia22031-

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By research site
Mayo Foundation for Medical Education and Research - Mayo Cl· Scottsdale, AZProvidence Medical Foundation· Fullerton, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CAYale Comprehensive Cancer Center· New Haven, CTThe University of Chicago Medical Center - Oncology· Chicago, ILNorton Cancer Institue Downtown· Louisville, KY

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