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BNT314 +/- Immune Checkpoint Inhibitor for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by BioNTech SE

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have adequate pancreas function at screening

Males who are sexually active and have not had a bilateral vasectomy or orchidectomy must agree to use condoms with a spermicidal agent and to require their female partners to practice a highly effective form of contraception during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from pre-dose to 21 days after study treatment for cycle 1

Awards & highlights

Study Summary

This trial investigates if a drug is safe and effective in treating various types of cancer.

Who is the study for?

Adults over 18 with advanced solid tumors that have worsened after standard treatment or who can't tolerate such treatments. They must be able to consent, follow study procedures, and have a life expectancy of more than 3 months. Good physical condition (ECOG score of 0 or 1) and proper organ function are required. Women must test negative for pregnancy and agree to contraception; men also need to use contraception.Check my eligibility

What is being tested?

The trial is testing BNT314's safety alone and combined with pembrolizumab in cancer patients. It has three parts: dose escalation to find the safest high dose, a safety run-in combining both drugs in a small group, followed by an expansion phase treating up to 199 patients with this combination.See study design

What are the potential side effects?

Potential side effects include typical reactions from immune therapies like inflammation in various organs, infusion-related symptoms, fatigue, digestive issues, blood disorders, increased risk of infections among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My pancreas is working well.

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I am a man who can father children and will use condoms and ensure my partner uses contraception during the study.

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My cancer has worsened after standard treatment, or I couldn't tolerate or wasn't eligible for it.

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from pre-dose to 21 days after study treatment for cycle 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from pre-dose to 21 days after study treatment for cycle 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-dose to 21 days after study treatment for cycle 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Combination therapy - Expansion. Objective response rate (ORR) based on investigator's tumor assessment according to RECIST 1.1

Combination therapy - SRI. Number and proportion of patients with occurrence of Grade ≥ 3 abnormal safety laboratory parameters

Combination therapy - SRI. Number and proportion of patients with occurrence of TEAEs including Grade ≥ 3, serious, fatal TEAE by relationship

+6 more

Secondary outcome measures

Combination therapy - Expansion. AUClast and AUCtau

Combination therapy - Expansion. Cmax from pre-dose to the end of the dosing period

Combination therapy - Expansion. DCR based on investigator's tumor assessment according to RECIST 1.1

+18 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: BNT314 MonotherapyExperimental Treatment1 Intervention

Escalating dose levels and backfill cohorts

Group II: BNT314 + pembrolizumabExperimental Treatment2 Interventions

The BNT314 starting dose for the SRI combination therapy will be one DL lower than the RP2D/MTD/maximum administered dose (MAD) determined from the monotherapy dose escalation.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

BioNTech SELead Sponsor

64 Previous Clinical Trials

107,338 Total Patients Enrolled

GenmabIndustry Sponsor

56 Previous Clinical Trials

11,872 Total Patients Enrolled

BioNTech Responsible PersonStudy DirectorBioNTech SE

33 Previous Clinical Trials

9,424 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots available for prospective participants in this clinical trial?

"Confirmed, this trial is not actively seeking out patients. The first posting was on December 1st 2023 and the last update occurred on November 21st 2023. Nevertheless, there are still 2591 other trials that require recruitment of volunteers at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Preliminary Efficacy of BNT314 With or Without an Immune Checkpoint Inhibitor in Cancer Patients With Malignant Solid Tumors

2023. "Safety and Preliminary Efficacy of BNT314 With or Without an Immune Checkpoint Inhibitor in Cancer Patients With Malignant Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06150183.

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