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New treatment option for Squamous Non-small-cell Lung Cancer
Official title A Study to Investigate ALE.P02 as Monotherapy in Adult Patients With Selected CLDN1+ Solid Tumors
ClinicalTrials.gov ID: NCT06747585
What this study is testing
What is ALE.P02?
ALE.P02 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for squamous non-small-cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Have disease and treatment history as: Have histologically or cytologically confirmed advanced locally recurrent and inoperable or metastatic...
- 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.
You likely can't join if
- 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...
See the full eligibility 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.
- 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...
- Concomitant use of drugs that are known to prolong or shorten QT and/or have known risk of Torsades de Pointes.
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Fullerton, California, United States
- Los Angeles, California, United States
- New Haven, Connecticut, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, United States
- Hackensack, New Jersey, United States
- Fairfax, Virginia, United States
- Bordeaux, France
- Dijon, France
- Lille, France
- Marseille, France
- Toulouse, France
- Villejuif, France
- Shatin, N.T., Hong Kong
- Milan, Italy
- Ravenna, Italy
- Roma, Italy
- Verona, Italy
- Singapore, South West, Singapore
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Fullerton, California, United States; Los Angeles, California, United States; New Haven, Connecticut, United States; Chicago, Illinois, United States; Louisville, Kentucky, United States and 25 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.