BNT329 for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called BNT329 for individuals with certain advanced cancers that no longer respond to standard therapies. The main goals are to assess the safety of BNT329, determine the optimal dose, and evaluate its effectiveness by observing any tumor shrinkage or stability. Participants will receive BNT329 in various ways to identify the most effective dosing schedule. Individuals who have battled advanced cancers like pancreatic, bladder, or ovarian cancer and have not succeeded with other treatments might be suitable for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I need to stop taking my current medications to join the trial?
The trial does not clearly specify if you need to stop taking your current medications. However, you must have an adequate washout period (time without taking certain medications) for prior anticancer treatments before starting the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that BNT329 is likely to be safe for humans?
Research shows that BNT329 is under study to determine its safety for treating solid tumors. Researchers closely monitor participants' responses to the treatment. In similar studies, mRNA-based treatments have generally been safe, with only rare serious side effects. This suggests that BNT329 might also be safe, but more data is needed for certainty.
In these trials, participants receive varying doses of BNT329 to assess reactions. Researchers evaluate the number and severity of side effects to identify the safest dose. For those considering joining a trial, it's important to know that researchers prioritize treatment safety.12345Why are researchers excited about this study treatment for solid tumors?
BNT329 is unique because it targets solid tumors with a fresh approach, using a specialized mechanism. Unlike traditional chemotherapy, which attacks all rapidly dividing cells, BNT329 is designed to specifically target cancer cells, potentially sparing more healthy tissue. Researchers are excited because it incorporates a new delivery method, where the drug is administered after pre-dosing with a CA19-9 targeting monoclonal antibody, which may enhance its effectiveness. This innovative strategy could offer a more targeted and potentially less toxic treatment option for patients with solid tumors compared to existing therapies.
What evidence suggests that BNT329 might be an effective treatment for solid tumors?
Research has shown that BNT329 is under investigation for its potential to treat advanced solid tumors. The trial evaluates BNT329 in various dosing schedules and combinations. One part of the trial administers BNT329 after pre-dosing with a CA19-9 targeting monoclonal antibody, as BNT329 targets a specific protein called CA19-9, found in some tumor cells. This protein is linked to tumor growth in cancers like pancreatic cancer. Early results suggest that targeting CA19-9 might slow or stop tumor growth. Although these initial findings are promising, further research is needed to confirm these effects.12467
Who Is on the Research Team?
BioNTech Response Person
Principal Investigator
BioNTech SE
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors expressing CA19-9, such as pancreatic, bile duct, bladder, colorectal, esophagogastric junction cancers, endometrial carcinoma or ovarian cancer. Participants must have tried all standard treatments without success and be in good physical condition with a life expectancy of at least 3 months.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BNT329 in a dose escalation format to evaluate safety and tolerability
End of Treatment Visit
Participants undergo an end of treatment evaluation
Safety Follow-Up
Two safety follow-up visits to monitor for adverse events
Survival Follow-Up
Participants are monitored for survival until death, withdrawal of consent, or study termination
What Are the Treatments Tested in This Trial?
Interventions
- BNT329
Find a Clinic Near You
Who Is Running the Clinical Trial?
BioNTech SE
Lead Sponsor
Prof. Dr. Ugur Sahin
BioNTech SE
Chief Executive Officer since 2008
MD from University of Cologne
Prof. Özlem Türeci
BioNTech SE
Chief Medical Officer since 2018
MD from Saarland University