Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05262530|
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : February 23, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Biological: BNT142||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||288 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 28, 2022|
|Estimated Primary Completion Date :||October 2025|
|Estimated Study Completion Date :||April 2026|
- Occurrence of treatment emergent adverse events (TEAEs) including Grade ≥3, serious, or fatal TEAEs by causal relationship to trial treatment [ Time Frame: From first dose to 60 days after the last dose of BNT142 ]
- Occurrence of dose reductions and discontinuation of BNT142 due to TEAEs [ Time Frame: From first dose to 60 days after the last dose of BNT142 ]
- Part 1: Occurrence of dose-limiting toxicities (DLTs) during the DLT evaluation period (Cycle 1, i.e., 21 days after the first dose) during the dose escalation [ Time Frame: assessed during the first cycle (21 days) in each cohort ]
- Part 2: Objective response rate (ORR) [ Time Frame: at least 48 months subsequent to first dose, are lost to follow-up, or have died ]ORR is defined as the proportion of patients in whom a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, and per Gynecological Cancer Intergroup (GCIG) criteria incorporating RECIST 1.1 and cancer antigen (CA) 125 for the ovarian cancer population is the best overall response.
- Part 1: PK parameter: Area under the concentration-time curve in the dosing interval (AUC) [ Time Frame: pre-dose until 60 days after last dose ]
- Part 1: PK parameter: Clearance (CL) [ Time Frame: pre-dose until 60 days after last dose ]
- Part 1: PK parameter: Volume of distribution (Vd) [ Time Frame: pre-dose until 60 days after last dose ]
- Part 1: PK parameter: Maximum observed concentration (Cmax) [ Time Frame: pre-dose until 60 days after last dose ]
- Part 1: PK parameter: Time to maximum observed concentration (Tmax) [ Time Frame: pre-dose until 60 days after last dose ]
- Part 1: PK parameter: Concentration prior to next dose (Ctrough) [ Time Frame: pre-dose until 60 days after last dose ]
- Part 1: PK parameter: Minimum observed concentration (Cmin) [ Time Frame: pre-dose until 60 days after last dose ]
- Part 1: PK parameter: Elimination half-life (t½) [ Time Frame: pre-dose until 60 days after last dose ]
- Disease control rate (DCR) [ Time Frame: at least 48 months subsequent to first dose, are lost to follow-up, or have died ]DCR is defined as the proportion of patients in whom a CR or PR or stable disease (SD) (per RECIST 1.1 [and per GCIG criteria for ovarian cancer patients], SD assessed at least 6 weeks after first dose) as best overall response.
- Duration of response (DOR) [ Time Frame: at least 48 months subsequent to first dose, are lost to follow-up, or have died ]DOR is defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression (progressive disease per RECIST 1.1) or death from any cause, whichever occurs first.
- Part 1: ORR [ Time Frame: at least 48 months subsequent to first dose, are lost to follow-up, or have died ]ORR (Part 1 only; this is a primary endpoint for Part 2) is defined as the proportion of patients in whom a CR or PR, per RECIST 1.1, is the best overall response.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Key Inclusion Criteria:
For Part 1 and 2:
- Histological or cytological documentation of a solid tumor that is metastatic or unresectable via a pathology report.
- 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.
Key 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05262530
|Contact: BioNTech clinical trials patient information||+49 6131 9084 ext email@example.com|
|United States, California|
|Cedars-Sinai Medical Center||Not yet recruiting|
|Los Angeles, California, United States, 90048|
|United States, Indiana|
|Indiana University School of Medicine||Not yet recruiting|
|Indianapolis, Indiana, United States, 46202|
|United States, Maryland|
|University of Maryland Medical Center||Not yet recruiting|
|Baltimore, Maryland, United States, 21201|
|United States, New York|
|Memorial Sloan Kettering Cancer Center||Not yet recruiting|
|New York, New York, United States, 10065|
|United States, North Carolina|
|Duke University Medical Center||Not yet recruiting|
|Durham, North Carolina, United States, 27705|
|United States, Pennsylvania|
|University of Pennsylvania||Not yet recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|The University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|South Texas Accelerated Research Therapeutics (START) - San Antonio||Recruiting|
|San Antonio, Texas, United States, 78229|
|United States, Virginia|
|Fairfax, Virginia, United States, 22031|
|National University Cancer Institute - National University Hospital||Not yet recruiting|
|Singapore, Singapore, 119074|
|Hospital Universitario Vall D'Hebron||Recruiting|
|Barcelona, Spain, 08035|
|MD Anderson Cancer Center||Recruiting|
|Madrid, Spain, 28033|
|START Madrid-FJD Hospital Universitario Fundacion Jimenez Diaz||Recruiting|
|Madrid, Spain, 28040|
|START Madrid CIOCC Hospital Universitario HM Sanchinarro||Recruiting|
|Madrid, Spain, 28050|
|Hospital Universitario Virgen de la Victoria Campus Universitario de Teatinos||Not yet recruiting|
|Malaga, Spain, 29010|
|Study Director:||BioNTech Responsible Person||BioNTech SE|
|Responsible Party:||BioNTech SE|
|Other Study ID Numbers:||
2021-005481-18 ( EudraCT Number )
|First Posted:||March 2, 2022 Key Record Dates|
|Last Update Posted:||February 23, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
CLDN6-positive solid tumors