BNT142 for Solid Tumors
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking chemotherapy, molecularly-targeted agents, and immunotherapy at least 3 weeks before starting the study treatment. If you're on steroids, you must not exceed a daily dose equivalent to 10 mg of prednisone.
What data supports the effectiveness of the treatment BNT142 for solid tumors?
Research on similar treatments, like bispecific T cell engagers (BiTEs), shows they can help the immune system attack cancer cells in solid tumors. Studies suggest that these treatments work better when combined with other therapies that boost immune response, especially in tumors that don't naturally attract many immune cells.12345
What safety data exists for BNT142 or similar treatments in humans?
The research mentions that bispecific antibodies, which are similar to BNT142, have an excellent safety profile and are being developed for cancer treatment. However, some bispecific T-cell engagers have shown severe toxicity at therapeutic doses in solid tumors, indicating potential safety concerns.45678
What makes the drug BNT142 unique for treating solid tumors?
BNT142 is a novel treatment that uses mRNA technology to encode a T-cell engager, which helps the immune system target and destroy cancer cells more effectively. This approach is different from traditional treatments because it directly recruits T-cells to attack the tumor, potentially offering a more targeted and potent response against solid tumors.1491011
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
First-in-human, open-label, dose escalation safety and PK study of BNT142 in patients with advanced/metastatic CLDN6-positive solid tumors
Expansion
Phase IIa proof-of-concept study in expansion cohorts of CLDN6 positive advanced/metastatic ovarian cancer, NSCLC of non-squamous type, and testicular cancer patients
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BNT142 (Monoclonal Antibodies)