Cervical Squamous Cell Carcinoma study: ALE.P03
Official title A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
ClinicalTrials.gov ID: NCT07169734
What this study is testing
What is ALE.P03?
An investigational IV infusion drug being studied as a potential treatment for cervical squamous cell carcinoma and other CLDN1‑positive solid tumors.
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 study will look at how safe and tolerable ALE.P03 is, how the drug moves through the body, early signs it might shrink tumors, and what dose should be used in later trials.
- Who it's for
- Adults with advanced or metastatic CLDN1‑positive squamous solid tumors such as cervical, lung, colorectal, intra‑hepatic cholangiocarcinoma, or urothelial cancer.
- What's involved
- Participants will receive ALE.P03 as a single drug, have regular clinic visits for safety checks, blood tests, and imaging scans to monitor the tumor.
- Time commitment
- The trial runs for several months with multiple visits, including dosing visits and periodic follow‑up appointments.
- 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 histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous...
- Have documented radiological disease progression at study entry.
- Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to...
- 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.
You likely can't join if
- SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.
- 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...
- Has clinically significant gastrointestinal bleeding.
See the full eligibility criteria
- Have histologically and cytologically metastatic confirmed advanced or metastatic colorectal cancer, intrahepatic cholangiocarcinoma, squamous non-small cell lung cancer, urothelial carcinoma, and cervical squamous cell...
- Have documented radiological disease progression at study entry.
- Received 1-2 available systemic SOC regimens (based on local institutional guidelines) for advanced disease and being refractory or intolerant to treatment.
- 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.
- SqNSCLC and CSCC: diagnosed with a tumor of predominantly non-squamous histology result or adenocarcinoma.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, 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
- Houston, Texas, United States
- San Antonio, Texas, United States
- Fairfax, Virginia, United States
- Dijon, France
- Marseille, France
- Toulouse, France
- Villejuif, France
- Hong Kong, Hong-Kong, Hong Kong
- Milan, Italy
- Ravenna, Italy
- Rossano, Italy
- Siena, Italy
- Amsterdam, Netherlands
- Nijmegen, Netherlands
+ 12 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, but 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?
This study is enrolling now at Phoenix, Arizona, 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 and 26 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.