No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
180 (estimated)
Sponsor
Alentis Therapeutics AG · Industry
Who this trial is looking for
This trial is looking for adults with certain advanced cancers to see if a new treatment, ALE.P03, is safe and effective. Participants will need to provide tissue samples and have documented disease progression.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with advanced colorectal cancer.
I have been diagnosed with intrahepatic cholangiocarcinoma.
I have been diagnosed with squamous non-small cell lung cancer.
I have been diagnosed with urothelial carcinoma.
I have been diagnosed with cervical squamous cell carcinoma.
I have shown disease progression before joining the study.
I have tissue samples available for analysis.
I have a performance status of 0 or 1.
You may not be able to join if
I have a tumor that is predominantly of non-squamous histology.
I have received certain cancer treatments within the last few weeks.
I have rapidly progressing disease.
I have known active central nervous system metastases.
I have a history of certain lung diseases that required steroid treatment.
I have significant gastrointestinal bleeding.
I have an active infection that needs treatment.
I have any condition that might affect the results of the study.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.P03 monotherapy in adult patients with selected squamous solid tumors.
Trial Locations
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Status
Eligibility Criteria
Inclusion 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 carcinoma.
* Have documented radiological disease progres…
Inclusion 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 carcinoma.
* 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:
* 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.
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