Study on the Safety and Early Effects of BNT314 Alone or with an Immune Checkpoint Inhibitor in Cancer Patients with Solid Tumors

Sponsor: BioNTech SE

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06150183

Provider View

This clinical trial is exploring the safety of a new drug, BNT314, when used alone or with another cancer drug, pembrolizumab, in patients with various types of solid tumors. The study aims to find the best dose and understand how the treatment affects the cancer.

Patient Parameters

Program Overview

This study is the first to test BNT314 in humans to see if it is safe when used alone and when combined with pembrolizumab, a cancer drug. Patients will receive either BNT314 by itself or together with pembrolizumab. The study has several parts:

  • Dose Escalation: Patients will receive different doses of BNT314 to find the highest safe dose.
  • Safety Run-In: A small group will receive BNT314 with pembrolizumab to check safety.
  • Expansion: More patients will receive the combination to further test its safety and effects.

The study will later include a Phase 2 part to further explore the treatment's effects.

Description

This study involves patients with advanced solid tumors who have no other standard treatment options. It will test the safety and early effects of BNT314, both alone and with pembrolizumab.

  • Dose Escalation: Patients will receive increasing doses of BNT314 to find the safest dose.
  • Combination Therapy: BNT314 will be combined with pembrolizumab and given to patients in cycles.

The study will continue until the cancer progresses, side effects become unacceptable, or the patient chooses to stop. The combination therapy can last up to 2 years, and the entire study may last up to 3 years after the last patient starts treatment.

Eligibility Criteria

Inclusion Criteria

  • Able to give informed consent and follow study instructions.
  • Aged 18 or older.
  • Have measurable cancer.
  • Life expectancy of more than 3 months.
  • Good overall health with a performance status of 0 or 1.
  • Adequate blood clotting, bone marrow, liver, kidney, and pancreas function.
  • Women of childbearing potential must have a negative pregnancy test and use effective contraception.
  • Men must use condoms and agree not to donate sperm during and after treatment.
  • Have advanced solid tumors that have progressed after standard therapy or are not eligible for standard therapy.

Exclusion Criteria

  • Uncontrolled illness or infection.
  • Heart problems or recent heart attack.
  • Uncontrolled high blood pressure.
  • History of severe immune-related side effects from previous treatments.
  • Chronic liver disease or pancreatitis.
  • Brain metastases unless stable and treated.
  • Recent major surgery or radiation therapy.
  • Recent use of other cancer treatments or investigational drugs.
  • Positive tests for hepatitis B or C.
  • Alcohol dependency or other conditions that could affect participation.
  • Participation in another investigational study.

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