Actively Recruiting
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
Led by BioNTech SE · Updated on 2026-04-17
482
Participants Needed
14
Research Sites
301 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
G
Genmab
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 therapy before for their cancer.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have unresectable, confirmed adenocarcinoma of the colon or rectum
- Have microsatellite stable or mismatch repair proficient metastatic colorectal cancer
- Have measurable disease according to RECIST v1.1 criteria
- Provide a tumor tissue sample collected before first treatment day, preferably recent or less than 2 years old
- Have an Eastern Cooperative Oncology Group Performance Status of 0 or 1
- Have a life expectancy of at least 12 weeks
- Have adequate organ and bone marrow function within 7 days before first treatment
- Have completed an adequate treatment washout period before enrollment
- For specific cohorts: have received at least two prior therapies for metastatic disease or have not received prior systemic therapy for MSS/pMMR mCRC
- Other cohort-specific inclusion criteria may apply
You will not qualify if you...
- Have microsatellite instability-high or deficient mismatch repair metastatic colorectal cancer
- Prior treatment with epithelial cell-adhesion molecule, 4-1BB targeted therapies, immune checkpoint inhibitors, or PD-L1/VEGF bispecific antibodies
- Eligible for locoregional treatments with potential for complete tumor control
- Have uncontrolled or significant cardiovascular disease
- Have left ventricular ejection fraction below 50% within 28 days before enrollment
- Have active pleural effusion, ascites, or pericardial effusion needing drainage within 2 weeks before enrollment
- Have active, untreated, or symptomatic brain metastases or require corticosteroids or anticonvulsants for CNS symptoms
- Have unresolved toxicities from previous cancer treatments above Grade 1 except alopecia
- Have had unusual toxicity from prior anticancer therapies or known dihydropyrimidine dehydrogenase deficiency if applicable
- Have another primary malignancy within 2 years except certain treated skin or low-risk cancers
- Have history of small bowel obstruction requiring hospitalization in past 3 months
- Have urine protein over 1 g in 24-hour collection or qualitative protein 1+ or higher
- Have autoimmune disease with risk of worsening after PD-L1 inhibition or immune deficiency
- Have serious non-healing wounds, ulcers, or fractures including recent gastrointestinal perforations or bleeding
- Have major blood clotting disorders or significant bleeding risks
- Other protocol-defined exclusion criteria may apply
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
2
START Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Actively Recruiting
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
5
Hämatologisch-Onkologische Praxis Eppendorf - HOPE
Hamburg, Germany, 20249
Actively Recruiting
6
Asklepios Tumorzentrum Hamburg
Hamburg, Germany, 22763
Actively Recruiting
7
National Cancer Center Hospital
Chūōku, Japan, 104-0045
Actively Recruiting
8
National Cancer Center Hospital East
Kashiwa, Japan, 277-8577
Actively Recruiting
9
Hospital HM Nou Delfos
Barcelona, Spain, 08023
Actively Recruiting
10
Vall D'Hebrón Hospital
Barcelona, Spain, 08035
Actively Recruiting
11
Centro Integral Oncologico Clara Campal
Madrid, Spain, 28050
Actively Recruiting
12
Guy's & St Thomas' NHS Foundation Trust, Guy's Hospital
London, United Kingdom, SE19RT
Actively Recruiting
13
Christie NHS Foundation
Manchester, United Kingdom, M20 4BX
Actively Recruiting
14
The Royal Marsden NHS
Sutton, United Kingdom, SM2 5PT
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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