A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Alentis Therapeutics AG
Study ID
NCT07169734
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • ALE.P03 — DRUG
    ALE.P03, will be administered by IV infusion according to the assigned arms.
  • ALE.P03 — DRUG
    ALE.P03, will be administered by IV infusion according to the assigned arms.
  • ALE.P03 — DRUG
    ALE.P03, 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.P03 monotherapy in adult patients with selected squamous solid tumors.

Key Dates

Start date
Aug 26, 2025
Status verified
Sep 2025
Primary completion
Apr 5, 2029
Completion
Oct 4, 2029

Study Design

Enrollment
180 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase I Dose Escalation- ALE.P03
    Patients will receive ALE.P03 as monotherapy via intravenous infusion. The ALE.P03 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.P03
    Patients will receive ALE.P03 as monotherapy via intravenous infusion. The safe recommended doses of ALE.P03 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.P03
    Patients will receive ALE.P03 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) (Phase I) [ Time Frame: Up to 28 days ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Mayo Clinic Comprehensive Cancer CenterPhoenixArizona85054
Principal Investigator
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Principal Investigator
Yale Comprehensive Cancer CenterNew HavenConnecticut06510
Principal Investigator
Norton Cancer Institute - Norton Healthcare PavilionLouisvilleKentucky40202
Principal Investigator
John Theurer Cancer CenterHackensackNew Jersey07601
Principal Investigator
MD Anderson Cancer CenterHoustonTexas77030
Principal Investigator
Next Oncology-OncologySan AntonioTexas78229
Principal Investigator
NEXT Oncology VirginiaFairfaxVirginia22031
Principal Investigator

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Mayo Clinic Comprehensive Cancer Center· Phoenix, AZUSC Norris Comprehensive Cancer Center· Los Angeles, CAYale Comprehensive Cancer Center· New Haven, CTNorton Cancer Institute - Norton Healthcare Pavilion· Louisville, KYJohn Theurer Cancer Center· Hackensack, NJMD Anderson Cancer Center· Houston, TX

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