Safety and Early Effectiveness Study of BNT142 in Patients with CLDN6-positive Solid Tumors

Sponsor: BioNTech SE

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05262530

Provider View

This clinical trial is testing a new drug, BNT142, to see if it is safe and effective for patients with advanced solid tumors that are positive for Claudin 6 (CLDN6). The study will first determine the best dose and then expand to include more patients with specific types of cancer.

Patient Parameters

Program Overview

This study is designed to test the safety and how the body processes a new drug called BNT142 in patients with advanced solid tumors that are positive for a protein called Claudin 6 (CLDN6). The study will start by finding the right dose and then move on to see how well the drug works in patients with certain types of cancer, such as ovarian, non-small cell lung, and testicular cancer, who have not responded to previous treatments.

Description

The study is divided into two parts:

Part 1: This is the first time BNT142 is being tested in humans. It will focus on finding a safe dose for patients with advanced or metastatic CLDN6-positive solid tumors. Patients will receive increasing doses of BNT142 to determine the safest and most effective dose.

Part 2: Once the safe dose is found, the study will expand to include more patients with specific types of cancer, such as ovarian cancer, non-small cell lung cancer (NSCLC) of non-squamous type, and testicular cancer. These patients must have tumors that are positive for CLDN6 and have not responded to previous treatments.

Eligibility Criteria

Inclusion Criteria

  • Have a solid tumor that is metastatic (spread to other parts of the body) or cannot be removed by surgery.
  • Tumor must be positive for CLDN6, confirmed by a lab test.
  • Have measurable disease according to specific medical criteria.

For Part 1:

  • Have advanced or metastatic ovarian, non-squamous NSCLC, endometrial, or testicular cancer, with no standard treatment options available.
  • Have tried all available standard treatments and not responded to at least the first line of therapy.

Exclusion Criteria

  • Have received chemotherapy or targeted therapy within 3 weeks or 5 half-lives before starting the study treatment.
  • Have had radiotherapy within 6 weeks before the first dose of BNT142, except for brain radiotherapy, which is allowed 3 weeks prior.
  • Are on systemic steroid therapy greater than 10 mg of prednisone daily.
  • Have had major surgery within 4 weeks before the first dose of BNT142.
  • Have an active infection requiring IV treatment within 2 weeks before the first dose of BNT142.
  • Have previously been treated with a CLDN6 targeting therapy.
  • Have not recovered from side effects of previous treatments to a mild level, except for certain conditions like fatigue or thyroid issues.
  • Have new or growing brain metastases, unless treated and stable.
  • Are pregnant, breastfeeding, or planning to become pregnant within 6 months after the last dose of BNT142.

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