Clinical Trials List
2025-04-01 - 2028-08-31
Phase I/II
Recruiting4
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
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/04/10
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
• Incidence and severity of AE and SAE
• Clinically significant changes in laboratory values, vital signs, and ECG
• Tolerability: Dose interruption and dose intensity
• Preliminary efficacy parameters according to RECIST 1.1:
• ORR defined as CR rate + PR rate
• DoR: Duration of response
Note: CLDN1 and indication subgroup analyses will also be performed.
• ORR, defined as CR rate + PR rate according to RECIST 1.1
• DoR: Duration of response
Note: CLDN1 and indication subgroup analyses will also be performed.
Inclution 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.
The Estimated Number of Participants
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Taiwan
40 participants
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Global
170 participants
