What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy, immunotherapy, and targeted therapies, have a range of side effects. Chemotherapy agents like oxaliplatin can cause neuropathy, diarrhea, nausea, and fatigue. Immunotherapies like pembrolizumab are associated with pneumonitis, diarrhea, rash, and pruritus. Targeted therapies like bevacizumab can lead to hypertension, deep venous thrombosis, and gastrointestinal perforation. These side effects vary in severity and frequency, and patient-specific factors often influence their occurrence.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of solid tumors, focusing on specific proteins or pathways involved in tumor growth and progression. Examples include pembrolizumab, an anti-PD-1 antibody used for various solid tumors, and cetuximab, an EGFR inhibitor for head and neck cancers. While specific FDA approvals for Claudin 6-targeting therapies like BNT142 are not mentioned, the trend towards personalized medicine and targeted treatments continues to grow, with ongoing research and clinical trials exploring new targets and mechanisms.

What other types of research exist?

Promising novel alternatives to BNT142 for solid tumor patients include: 1) Ramucirumab, a monoclonal antibody for pretreated gastric cancer, which is a milestone in antiangiogenic therapy. 2) TAS-118, TAS-102, and STAT3 inhibitors, which are in early clinical trials and show encouraging results. 3) IMAB362 (anti-Claudin 18.2), which targets a similar pathway as BNT142. 4) Immune checkpoint inhibitors, which have shown potential in various solid tumors and warrant further evaluation in larger clinical trials.

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Monoclonal Antibodies

BNT142 for Solid Tumors

Phase 1 & 2

Recruiting

Research Sponsored by BioNTech SE

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histological or cytological documentation of a solid tumor that is metastatic or unresectable via a pathology report.

Be older than 18 years old

Must not have

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.

Prior treatment with a CLDN6 targeting monoclonal antibody.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months after last patient last dose

Awards & highlights

No Placebo-Only Group

Summary

This trial tests BNT142, an experimental drug, on patients with advanced cancers that have a specific protein (CLDN6). The drug aims to help the immune system target and destroy these cancer cells.

Who is the study for?

This trial is for adults with solid tumors that are CLDN6-positive, metastatic or cannot be surgically removed. They must have tried all standard treatments without success and not received certain therapies within specific time frames before the trial. Pregnant or breastfeeding individuals, those with new brain metastases, or on high-dose steroids are excluded.

What is being tested?

The clinical trial is testing BNT142 in patients with advanced CLDN6-positive tumors. It's an early-phase study to determine safe dosage levels and initial effectiveness while monitoring how the body processes the drug across multiple centers.

What are the potential side effects?

While specific side effects of BNT142 aren't listed here, common ones from similar trials may include fatigue, nausea, immune-related reactions, infusion site discomfort, and potential impacts on blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has spread or cannot be removed by surgery, confirmed by a pathology report.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking more than 10 mg of prednisone daily for a condition other than hormone replacement.

Select...

I have been treated with a CLDN6 targeting antibody before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months after last patient last dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months after last patient last dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months after last patient last dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 2: Objective response rate (ORR)

Secondary study objectives

Disease control rate (DCR)

Duration of response (DOR)

Part 1: ORR

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: BNT142Experimental Treatment1 Intervention

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for solid tumors include targeted therapies, immunotherapies, chemotherapy, and radiation. Targeted therapies, such as those being studied in the BNT142 trial, work by specifically targeting molecular markers like Claudin 6, which is overexpressed in certain tumors, thereby inhibiting tumor growth and spread. Immunotherapies boost the body's immune system to recognize and destroy cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, while radiation therapy uses high-energy particles to damage the DNA of cancer cells. These treatments are crucial for solid tumor patients as they offer multiple avenues to control and potentially eradicate the disease, improving survival rates and quality of life.