Not recruiting

A Phase 1/2a Study of BNT142 Safety and Early Effectiveness in Patients with Advanced Solid Tumors Expressing CLDN6 Protein

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial studies a new treatment called BNT142 for patients with solid tumors. The study focuses specifically on advanced cases of ovarian cancer, lung cancer, and testicular cancer that are positive for a specific marker called CLDN6. The medication is given as a dispersion for injection through infusion.

The main purpose of this research is to test how safe BNT142 is and to see how well it works in treating these types of cancers. The study is divided into two parts. In the first part, different dose levels of the medication will be tested to find the most appropriate dose. The second part will look more closely at how well the treatment works in fighting the cancer.

During the study, patients will receive BNT142 treatment, and doctors will monitor their health and how their cancer responds to the medication. The treatment targets specific features of cancer cells, particularly a protein found on the surface of certain tumor cells. The study will track various measures of the treatment's effectiveness, including whether tumors shrink or stop growing, and how long any positive effects last.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Confirmation of advanced solid tumor through tissue examination
Verification of CLDN6-positive tumor status through laboratory testing
Assessment of tumor size and location using imaging
Step 2
Treatment preparation
The treatment involves BNT142, administered as a solution through infusion
The study is divided into two parts: dose escalation (Part 1) and expansion (Part 2)
Your specific dosing schedule will be determined based on study part participation
Step 3
Treatment administration
Regular infusion sessions of BNT142
Monitoring for any side effects during and after infusions
Regular assessment of treatment response through imaging scans
Step 4
Ongoing monitoring
Regular measurement of tumor size using imaging tests
Blood tests to monitor treatment effects
Assessment of any side effects or complications
Documentation of treatment response, which may be classified as complete response, partial response, or stable disease
Step 5
Study completion
Final evaluation of treatment response
Assessment of overall health status
Documentation of any lasting effects from the treatment

Who can join the trial?

11 criteria

Patient must have a solid tumor that has spread (metastatic) or cannot be removed by surgery, confirmed by tissue examination
The tumor must test positive for CLDN6 (a specific protein marker) using a special laboratory test called CLAUDENTIFY®6 on preserved tumor tissue or fresh tissue samples
The tumor must be measurable using standard imaging criteria (RECIST 1.1)
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For the first part of the study, patients must have one of these cancers:
- Advanced ovarian cancer (including fallopian tube and peritoneal cancer)
- Non-squamous lung cancer (NSCLC)
- Endometrial cancer
- Testicular cancer
- Other rare tumors or cancers of unknown origin
- Patients must have already tried all available standard treatments for their cancer type, including targeted therapies, and their cancer must have progressed after at least one standard treatment
- Both men and women may participate in the study
- Patients must be adults (18 years or older)

Who cannot join the trial?

14 criteria

Any history of other cancer within the past 3 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ
Active brain metastases (spread of cancer to the brain) or spinal cord compression. Patients with previously treated brain metastases may participate if treatment was completed at least 4 weeks prior
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Severe heart conditions including:
- Heart attack within past 6 months
- Unstable angina (chest pain)
- Heart failure requiring treatment
- Active or chronic infections including HIV, Hepatitis B, or Hepatitis C
- Major surgery within 4 weeks before starting the study treatment
- Previous treatment with similar cancer therapies within 4 weeks before study start
- Pregnancy or breastfeeding
- Any serious medical condition that could interfere with study participation
- Known allergies to study medication components
- Participation in another clinical trial within 4 weeks before this study
- Mental conditions that could affect the ability to provide informed consent
- Use of systemic steroids or other immunosuppressive medications within 2 weeks before study start

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain

Trial locations

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Investigated drugs

BNT142 is an investigational therapy designed for patients with advanced solid tumors that are positive for CLDN6 (Claudin-6). This is a new treatment being tested for the first time in humans. It targets specific types of cancer cells that express the CLDN6 protein on their surface. The therapy is being evaluated for its safety and effectiveness in treating various types of solid tumors, with a particular focus on ovarian cancer among other cancer types.

What is already known about the treatment

BNT142 - An investigational therapeutic agent currently being studied in Phase I/IIa clinical trials for patients with CLDN6-positive advanced solid tumors. The drug is being evaluated for safety, tolerability, and preliminary efficacy in a first-in-human, open-label, multicenter study. The medication is designed to target CLDN6 (Claudin-6), a tumor-specific protein, making it a targeted therapy approach for various solid tumors, with particular attention to ovarian cancer where specific response criteria are being monitored. The clinical development includes dose-escalation studies to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), while also assessing pharmacokinetics and pharmacodynamics parameters.

Investigated diseases

Solid Tumors - A disease characterized by abnormal masses or growths of tissue that form when cells divide more than they should or do not die when they should. These masses can develop in almost any organ or tissue in the body and are made up of solid clusters of cells. Solid tumors grow gradually over time as cells continue to multiply abnormally. Unlike liquid tumors that affect blood cells, solid tumors form distinct masses that can often be felt or seen through imaging. They can occur in various parts of the body, including organs, muscles, bones, and other tissues.