BNT317 for Cancer

Recruiting at 7 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

Trial Summary

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.

What is the purpose of this trial?

This is a first-in-human (FIH), open-label, multiple-site, dose escalation study which will evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of increasing doses of BNT317 in participants with advanced solid tumors.

Research Team

BioNTech Responsible Person

Principal Investigator

BioNTech SE

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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