ClinicaliQ Trial Snapshot
- A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer — Recruiting • Phase I • Oncology • NCT07079631.
- Treatment Being Tested: BNT314 (immunotherapy) combined with BNT327 (immune checkpoint inhibitor) and chemotherapy in a randomised, multi-site design to evaluate efficacy and safety in advanced colorectal cancer.
- Patient Eligibility Overview: The study enrolls patients with advanced colorectal cancer; specific eligibility criteria (performance status, organ function, prior treatments) are detailed in the full protocol and determine who can participate across multiple UK sites.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's immune system fight cancer in combination with another new treatment (BNT327, which is an immune checkpoint inhibitor) and chemotherapy in participants with metastatic colorectal cancer (mCRC). This study will enroll participants with microsatellite stable or mismatch repair proficient (MSS/pMMR) mCRC who did not respond well to their first schema of chemotherapy. In one part of the study (i.e., Part B) mCRC participants will be enrolled, who have not received any systemic…
Eligibility Snapshot
- Key Inclusion Criteria: * Have unresectable histologically confirmed adenocarcinoma of the colon or rectum. * Have confirmed non-microsatellite instability-high (non-MSI-H)/pMMR mCRC per Food and Drug Administration (FDA)/European Commission (EC) approved test or based on local testing. * Have measurable disease defined by RECIST v1.1. * Must provide a tumor tissue sample (formalin-fixed, paraffin-embedded or tissue slides) collected before C1D1 for enrollment. A newly obtained tumor sample is preferred. If it is not feasible to obtain a recent tumor sample, participants can provide archival tumor tissue (less than 2 years prior treatment). * Have Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Have a life expectancy of ≥12 weeks. * Have an adequate organ and bone marrow function within ≤7 days of Day 1 as defined in the protocol. * Have had an adequate previous treatment washout period before randomization/enrollment as defined in the protocol. Inclusion criteria applicable to only protocol-specific cohorts: * Have received at least two previous lines of therapy for metastatic disease. * Have progressed following first-line chemotherapy as specified in the protocol. * Have not received prior systemic therapy for MSS/pMMR mCRC. Participants who received chemotherapy, radiotherapy, or chemoradiotherapy with curative intent for non-metastatic…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.