First-in-human, Open-label, Multicenter, Phase I/IIa, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT142 in Patients With CLDN6-positive Advanced Solid Tumors

Study Identifier:
BNT142-01
CT.gov Identifier:
NCT05262530
EudraCT Identifier:
2021-005481-18
EU Trial (CTIS) Number:
2024-512639-58-00
Study Contact Information:
(210) 593-5651 or [email protected]
Terminated/Withdrawn

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Study Summary

To evaluate BNT142 in multiple solid tumors.

To study about safety, and pharmacokinetics (PK) of BNT142 followed by expansion cohorts in patients with Claudin 6 (CLDN6)-positive advanced tumors.

The recommended Phase II dose (RP2D) will be determined by data collected at all dose levels (DL).

Part 1 (Dose escalation) of this study is a first-in-human (FIH), open-label, dose escalation safety and PK study of BNT142 in patients with advanced/metastatic CLDN6-positive solid tumors.

Part 2 (Expansion) will be a Phase IIa proof-of-concept study in up to three expansion cohorts of CLDN6 positive advanced/metastatic ovarian cancer, non-small cell lung cancer (NSCLC) of non-squamous type, and testicular cancer patients who have progressed on or after last prior treatment.

To evaluate weekly BNT142 treatment with premedication (antipyretics, antihistamines, fluids) at the investigators’ discretion in pts with CLDN6+ (≥10% of cells with at least weak membrane positivity) advanced solid tumors.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I/II
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: BNT142
    • Read More
  • Drug: Intervention:
  • Drug: ASCO 2023
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Terminated/Withdrawn

    Requirements information
    Inclusion criteria
    • For Part 1 and 2:
    • Histological or cytological documentation of a malignant solid tumor (via a pathology report) that is metastatic or unresectable.
    • CLDN6-positive tumor sample as assessed by central testing using a validated immunohistochemistry (IHC) assay in formalin-fixed paraffin-embedded (FFPE) neoplastic tissues or alternatively from fresh tissue if archival tissue is unavailable. If archival tissue samples from several points of time are available, the most recent one is preferred.
    • Measurable disease per RECIST 1.1 (measurable per RECIST 1.1 or evaluable per GCIG criteria for ovarian tumors).
    • For Part 1 (Dose escalation):
    • Patients with advanced/metastatic ovarian (including fallopian tube and peritoneal), non-squamous non-small cell lung cancer (NSCLC), endometrial, or testicular cancer, for whom there is no available standard therapy likely to confer clinical benefit, or the patient is not a candidate for such available therapy, or patients with not otherwise specified (NOS) tumors not included in the eligible tumor types, including rare tumors and cancers of unknown primary, upon approval by the medical monitor. Patients must have received all available standard therapies, including targeted therapies based on mutation status (per guidelines from the Food and Drug Administration (FDA), American Society of Clinical Oncology (ASCO), European Society for Medical Oncology (ESMO) or local guidelines used at the site), and failed at least first line standard of care (SOC) therapy prior to enrollment.
    • Patients with CLDN6+ metastatic or unresectable solid tumors: ovarian, GCT, non-squamous NSCLC, and other rare cancers CLDN6 positivity: 2≥10% of cells with any membrane positivity (prospective central CLDN6 testing)
    • • Patients have received all available standard therapies and progressed at least on first-line SOC therapy
    Exclusion criteria
    • Radiotherapy, chemotherapy, or molecularly-targeted agents within 3 weeks or 5 half-lives (whichever is longer) of the start of trial treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of trial treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of trial treatment.
    • Concurrent systemic (oral or intravenous [IV]) steroid therapy >10 mg prednisone daily or its equivalent for an underlying condition apart from physiologic corticosteroid replacement therapy.
    • Major surgery within 4 weeks before the first dose of BNT142.
    • Ongoing or active infection requiring IV treatment with anti-infective therapy that has been administered less than 2 weeks prior to the first dose of BNT142.
    • Prior treatment with a CLDN6 targeting monoclonal antibody.
    • Side effects of any prior therapy or procedures for any medical condition not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.5 Grade ≤1, except for anorexia, fatigue, hyperthyroidism, hypothyroidism, and peripheral neuropathy, which must have recovered to Grade ≤2. Alopecia of any grade is allowed.
    • Current evidence of new or growing brain or leptomeningeal metastases during screening. Patients with known brain metastases may be eligible if they:
    • Had radiotherapy, surgery or stereotactic surgery for the brain metastases;
    • Have no neurological symptoms (excluding Grade ≤2 neuropathy);
    • Have stable brain metastasis on the computer tomography (CT) or magnetic resonance imaging (MRI) scan within 4 weeks before signing the informed consent form (ICF); and
    • Are not undergoing acute corticosteroid therapy or steroid taper.
    • Notes: Patients with central nervous system (CNS) symptoms should undergo a CT scan or MRI of the brain to exclude new or progressive brain metastases. Spinal bone metastases are allowed, unless imminent fracture with cord compression is anticipated.
    • Pregnant or breastfeeding or planning to get pregnant within 6 months of the last dose of BNT142.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Victor Moreno Garcia
    Status
    Recruitment Complete
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Barcelona
    Barcelona, Spain, 08023
    Investigator
    Tatiana Hernandez Guerrero
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor