RecruitingPhase 1Phase 2NCT06747585
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
Sponsor
Alentis Therapeutics AG
Enrollment
170 participants
Start Date
Dec 16, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic SqNSCLC, HNSCC (nasopharyngeal cancer included), ESCC or CSCC.
- Phase I Dose Escalation: Have received at least one systemic standard of care regimen and being refractory or intolerant to the treatment.
- Phase I RDE and Phase II: Have received no more than 2 lines of systemic standard of care regimen and being refractory or intolerant to the treatment.
- Have provided tissue for CLDN1 analysis in a central laboratory.
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group Performance Scale.
- Demonstrate adequate bone marrow and organ function.
- Patients must have recovered from all toxicities led by prior treatment.
- Have measurable disease based on RECIST 1.1 as determined by the site.
Exclusion Criteria7
- Diagnosed with cancers of predominantly non-squamous histology (eg, adenosquamous carcinoma) or adenocarcinoma.
- Has received antineoplastic therapies prior to study intervention within specified time frame.
- Has rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain).
- Patients with uncontrolled diabetes.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has clinically significant gastrointestinal bleeding and has an active infection requiring systemic treatment and has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study, interfere with the patient's participation for the full duration of the clinical study, or is not in the best interest of the patient to participate.
- Concomitant use of drugs that are known to prolong or shorten QT and/or have known risk of Torsades de Pointes.
Interventions
DRUGALE.P02
ALE.P02, will be administered by IV infusion according to the assigned arms.
Locations(38)
View Full Details on ClinicalTrials.gov
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NCT06747585
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