A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
NCT ID: NCT07169734
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
180 participants
INTERVENTIONAL
2025-08-26
2029-10-04
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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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.
ALE.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
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.
ALE.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
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.
ALE.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
Interventions
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ALE.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
ALE.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
ALE.P03
ALE.P03, will be administered by IV infusion according to the assigned arms.
Eligibility Criteria
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Inclusion Criteria
* Have documented radiological disease progression at study entry.
* Have provided tissue for CLDN1 (Claudin-1) analysis in a central laboratory.
Phase I Dose Escalation:
\- Received and being refractory/intolerant to available systemic standard of care (SOC) regimens (based on local institutional guidelines) for advanced disease.
Phase I RDE and Phase II:
* Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.
* Patients with actionable oncogenic drivers: received feasible targeted therapy.
Applicable for Phase I Dose Escalation, Phase I RDE and Phase II:
* Measurable disease per RECIST 1.1, as determined by the site.
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Groups Performance Status.
* Demonstrate adequate bone marrow and organ function as per the protocol.
Exclusion Criteria
* Has received antineoplastic therapies prior to study intervention within specified time frame.
* Has rapidly progressing disease.
* Has known active central nervous system metastases and/or carcinomatous meningitis.
* Has a history of (non-infectious) interstitial lung disease/pneumonitis that required steroids or current symptomatic or clinically significant pneumonitis requiring steroids and/or immunosuppressive therapies.
* Has clinically significant gastrointestinal bleeding.
* Has an active infection requiring systemic treatment.
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the clinical study.
18 Years
ALL
No
Sponsors
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Alentis Therapeutics AG
INDUSTRY
Responsible Party
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Locations
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USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, United States
Norton Cancer Institute - Norton Healthcare Pavilion
Louisville, Kentucky, United States
John Theurer Cancer Center
Hackensack, New Jersey, United States
Next Oncology-Oncology
San Antonio, Texas, United States
NEXT Oncology Virginia
Fairfax, Virginia, United States
National Cancer Centre Singapore (NCCS)
Singapore, , Singapore
Countries
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Central Contacts
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Facility Contacts
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Principal Investigator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Principal Investigator
Role: primary
Other Identifiers
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2025-521441-24-00
Identifier Type: CTIS
Identifier Source: secondary_id
ALE.P03.01
Identifier Type: -
Identifier Source: org_study_id