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

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 as a monotherapy or in combination with pembrolizumab in adult patients with selected squamous solid tumors.

Trial Details

NCT ID
NCT06747585
Phase
PHASE1 / PHASE2
Sponsor
Alentis Therapeutics AG
Status
RECRUITING
Cancer Type
Non-Small Cell (NSCLC) Lung Cancer
Interventions
  • ALE.P02
Locations (sample)
  • Scottsdale, Arizona, United States|33.50921,-111.89903
  • Fullerton, California, United States|33.87029,-117.92534
  • Los Angeles, California, United States|34.05223,-118.24368
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Chicago, Illinois, United States|41.85003,-87.65005

Key Eligibility Criteria

  • Have disease and treatment history as: histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, H…
  • Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment.
  • Phase I Monotherapy RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to…
  • Phase I Combination Therapy RDE: Have received no previous systemic therapy in incurable recurrent or metastatic setting

For full eligibility, visit ClinicalTrials.gov.

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