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

Launched by ALENTIS THERAPEUTICS AG · Dec 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called ALE.P02 for adult patients with certain types of solid tumors, specifically squamous cell cancers such as lung, head and neck, cervical, and esophageal cancers. The main goals of the trial are to check how safe the treatment is, how well the body handles it, and to see if it has any effect on shrinking tumors. The researchers are also trying to find the best dose of ALE.P02 for future studies.

To participate in this trial, patients must have advanced or metastatic squamous cell cancer and have already tried at least one standard cancer treatment that didn't work or caused side effects they couldn't tolerate. Additionally, they need to have a specific type of cancer cell (CLDN1+) confirmed by lab tests and be in good enough health to take part. While the study is currently recruiting participants, those who join can expect to receive the treatment, regular check-ups, and monitoring to assess their health and response to the drug. It's important to note that patients with certain health issues or other types of cancer may not be eligible to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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.