Trial record 1 of 1 for:
BNT 142-01
Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid Tumors
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| ClinicalTrials.gov Identifier: NCT05262530 |
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Recruitment Status :
Recruiting
First Posted : March 2, 2022
Last Update Posted : April 3, 2024
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Sponsor:
BioNTech SE
Information provided by (Responsible Party):
BioNTech SE
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Brief Summary:
This study is an open-label, multicenter, Phase I/IIa, dose escalation, safety, and pharmacokinetics (PK) study of BNT142 followed by expansion cohorts in patients with Claudin 6 (CLDN6)-positive advanced tumors.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Solid Tumor | Biological: BNT142 | Phase 1 Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 330 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: BNT142 |
Biological: BNT142
Intravenous bolus/infusion |
Primary Outcome Measures :
- Occurrence of treatment emergent adverse events (TEAEs) including Grade ≥3, serious, or fatal TEAEs by causal relationship to study 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: up to 36 months after last patient last dose ]ORR is defined as the proportion of patients in whom a confirmed 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.
Secondary Outcome Measures :
- 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: up to 36 months after last patient last dose ]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: up to 36 months after last patient last dose ]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: up to 36 months after last patient last dose ]ORR (Part 1 only) is defined as the proportion of patients in whom a confirmed CR or PR, per RECIST 1.1, is the best overall response.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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 laboratory testing using a validated immunohistochemistry (IHC) assay in formalin-fixed paraffin-embedded 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 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 (as confirmed by histological diagnosis), rare tumors (defined as those occurring in <15 out of 100,000 people each year as per National Cancer Institute [NCI] guidelines) and cancers of unknown primary, not included in the pre-defined eligible tumor types. Patients must have received all available standard therapies, including targeted therapies based on mutation status (per guidelines from the US 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 therapy prior to enrollment.
Key Exclusion Criteria:
- Chemotherapy, or molecularly-targeted agents within 3 weeks or 5 half-lives (whichever is longer) of the start of study treatment; immunotherapy/monoclonal antibodies within 3 weeks of the start of study treatment; nitrosoureas, antibody-drug conjugates, or radioactive isotopes within 6 weeks of the start of study treatment.
- Radiotherapy in the last 6 weeks prior to the first dose of BNT142 (excluding brain radiotherapy for which 3 weeks prior to the first dose of BNT142 is allowed). Previously irradiated tumor lesions cannot be considered as target lesions or non-target lesions in this study.
- 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 therapy.
- Side effects of any prior therapy or procedures for any medical condition not recovered to National Cancer Institute Common Terminology Criteria for Adverse Events 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; and
- Are not undergoing acute corticosteroid therapy or steroid taper.
- Notes: Patients with central nervous system 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.
Information from the National Library of Medicine
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
Contacts
| Contact: BioNTech clinical trials patient information | +49 6131 9084 ext 0 | patients@biontech.de |
Locations
Show 23 study locations
Sponsors and Collaborators
BioNTech SE
Investigators
| Study Director: | BioNTech Responsible Person | BioNTech SE |
| Responsible Party: | BioNTech SE |
| ClinicalTrials.gov Identifier: | NCT05262530 |
| Other Study ID Numbers: |
BNT142-01 2021-005481-18 ( EudraCT Number ) |
| First Posted: | March 2, 2022 Key Record Dates |
| Last Update Posted: | April 3, 2024 |
| Last Verified: | April 2024 |
| 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 |
Keywords provided by BioNTech SE:
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CLDN6-positive solid tumors |
Additional relevant MeSH terms:
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Neoplasms |