BNT317 for Cancer

Recruiting at 9 trial locations

Overseen By BioNTech clinical trials patient information

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: BioNTech SE

Must not be taking: CD39 inhibitors, Live vaccines

Disqualifiers: Uncontrolled hypertension, Diabetes, CNS metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 100

39 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BNT317 for individuals with advanced solid tumors, which are cancers that have spread and lack other treatment options. The researchers aim to determine the safety of BNT317, how the body processes it, and its effects on the immune system. The study explores different doses of BNT317 to identify the optimal one. Individuals who have exhausted other treatments or lack alternatives may be suitable candidates for this trial. As a Phase 1 trial, this research seeks to understand how BNT317 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires stopping certain medications before participating. You must not have taken specific treatments like chemotherapy, immunotherapy, or corticosteroids above a certain dose within a few weeks before starting the trial. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that BNT317 is likely to be safe for humans?

Research shows that BNT317 is undergoing its first human testing to assess safety. This new treatment is studied to determine how well individuals tolerate it. The study identifies any side effects, particularly serious ones. Trial participants receive varying doses of BNT317 to find the right balance between safety and effectiveness.

As an early trial, the main goal is to learn about potential side effects and how the treatment functions in the body. BNT317 is not yet approved for any condition, so the study aims to gather crucial safety information. The trial is carefully monitored to ensure participant safety, and any adverse side effects are closely tracked. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BNT317 for cancer because it represents a novel approach compared to existing treatments like chemotherapy and radiation. Unlike these traditional options, BNT317 is a type of monotherapy that may offer a more targeted mechanism of action, potentially leading to fewer side effects. This innovative treatment is administered through different dosage levels, allowing for flexibility and personalization in patient care. By focusing on specific cancer pathways, BNT317 could enhance treatment effectiveness and improve patient outcomes.

What evidence suggests that BNT317 might be an effective treatment for cancer?

Research has shown that BNT317 targets advanced solid tumors by harnessing the body's immune system. It enhances the body's ability to identify and attack cancer cells. Early results appear promising, but specific information on its effectiveness in humans remains limited due to its novelty. This trial will evaluate BNT317 at various dose levels to assess its safety and how the body processes different doses. Scientists hope that BNT317 could offer new treatment options for difficult-to-manage cancers. ^{1 2 5 6 7}

Who Is on the Research Team?

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors who have tried other treatments without success. Participants must be adults with measurable disease, adequate organ function, and a life expectancy of at least 3 months. They cannot join if they have brain metastases, uncontrolled illnesses, or are pregnant.

Inclusion Criteria

My advanced cancer has not responded to standard treatments, or there are none suitable for me.

My blood counts and organ functions are within normal ranges.

I have a tumor that can be measured and hasn't been treated yet.

Exclusion Criteria

I have had a stem cell or organ transplant.

My blood pressure or diabetes is not well-managed.

I haven't taken high doses of steroids in the last 2 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive BNT317 at escalating doses to evaluate safety, tolerability, and determine the maximum tolerated dose

up to 2 years

Regular visits as per dose escalation protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks

Follow-up visits up to 100 days after last dose

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• BNT317

Trial Overview The study tests increasing doses of BNT317 to find the safest and most effective level for treating advanced solid tumors. It's an early-stage trial that looks at how the body reacts to the drug (pharmacokinetics) and whether it triggers immune responses (immunogenicity).

How Is the Trial Designed?

Group I: BNT317 DL7 (optional, additional) Experimental Treatment 1 Intervention

BNT317 monotherapy

Group II: BNT317 DL6 (optional, intermediate) Experimental Treatment 1 Intervention

BNT317 monotherapy

Group III: BNT317 DL5 (optional, intermediate) Experimental Treatment 1 Intervention

BNT317 monotherapy

Group IV: BNT317 DL4 Experimental Treatment 1 Intervention

BNT317 monotherapy

Group V: BNT317 DL3 Experimental Treatment 1 Intervention

BNT317 monotherapy

Group VI: BNT317 DL2 Experimental Treatment 1 Intervention

BNT317 monotherapy

Group VII: BNT317 DL1 Experimental Treatment 1 Intervention

BNT317 monotherapy

Who Is Running the Clinical Trial?

BioNTech SE

Lead Sponsor

Trials

84

Recruited

120,000+

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06750185

Study Details | NCT06750185 | Safety and Preliminary ... Participants will be assigned to one of four dose levels of BNT317. One treatment cycle contains one treatment. Participants may receive investigational ...

2. clinicaltrials.biontech.com clinicaltrials.biontech.com/trials/BNT317-01

Safety and Preliminary Effectiveness of BNT317, an ... This is a first-in-human (FIH), open-label, multiple-site, dose escalation study which will evaluate the safety, tolerability, pharmacokinetics (PK), and ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/563755

Safety and Preliminary Effectiveness of BNT317, an ... This is a first-in-human (FIH), open-label, multiple-site, dose escalation study which will evaluate the safety, tolerability, pharmacokinetics (PK), ...

4. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/563755

Safety and Preliminary Effectiveness of BNT317, an ... This is a first-in-human (FIH), open-label, multiple-site, dose escalation study which will evaluate the safety, tolerability, ...

5. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/BNTX/pressreleases/35737951/biontechs-bnt317-study-a-new-hope-for-advanced-solid-tumors/

BioNTech's BNT317 Study: A New Hope for Advanced ... The study aims to evaluate the safety and preliminary effectiveness of BNT317, an investigational therapy for advanced solid tumors. This ...

6. clin.larvol.com clin.larvol.com/trial-detail/NCT06750185

Safety and Preliminary Effectiveness of BNT317, an ... Per dose group. Assessed according to (US National Cancer Institute) Common Terminology Criteria for Adverse Events version 5.0, including Grade ≥3, serious, ...

7. biontech.com biontech.com/int/en/home/pipeline-and-products/pipeline.html

Pipeline BNT113 is an mRNA cancer immunotherapy candidate encoding a fixed set of two oncoproteins that are frequently found in human papillomavirus type 16 positive (“ ...