Actively Recruiting
A Phase I/II, Randomized, Multi-site Trial to Investigate the Efficacy and Safety of BNT314 in Combination With BNT327 and Chemotherapy in Participants With Metastatic Colorectal Cancer
Led by BioNTech SE · Updated on 2026-04-17
482
Participants Needed
14
Research Sites
21 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
G
Genmab
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment called BNT314 combined with another investigational drug, BNT327, and chemotherapy for people with metastatic colorectal cancer (mCRC) that is microsatellite stable or mismatch repair proficient (MSS/pMMR). The study focuses on participants whose cancer did not respond well to first-line chemotherapy or who have not received systemic therapy before. The trial is divided into three parts to assess safety, dosing, and effectiveness of the treatments in shrinking or controlling tumor growth. The study treatments include varying doses of BNT314 and BNT327, given by intravenous infusion, along with one of two standard chemotherapy regimens or Bevacizumab combined with chemotherapy. Part A tests safety and dose levels, Part B optimizes the dose of BNT314 with chemotherapy, and Part C compares the combination treatments to standard care in a randomized manner. Participants receive treatment until disease progression, intolerance, or study end, with an expected average treatment duration of 6 to 10 months. Participants will undergo screening, treatment, and safety follow-up periods, followed by long-term monitoring for survival and side effects. Researchers will regularly assess safety through an internal review committee and independent monitoring for Part C. Outcome measures include dose limiting toxicities, adverse events, tumor response rates, progression-free survival, and overall survival, with assessments continuing for up to 57 months after treatment begins.
CONDITIONS
Brief 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 histologically confirmed adenocarcinoma of the colon or rectum.
- Have confirmed non-microsatellite instability-high (non-MSI-H)/pMMR metastatic colorectal cancer.
- Have measurable disease as defined by RECIST v1.1.
- Provide a tumor tissue sample collected before starting treatment; newly obtained preferred, archival allowed if less than 2 years old.
- Have 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 starting treatment.
- Have completed an adequate previous treatment washout period before enrollment.
- Have received at least two previous lines of therapy for metastatic disease (for specific cohorts).
- Have progressed following first-line chemotherapy (for specific cohorts).
- Have not received prior systemic therapy for MSS/pMMR metastatic colorectal cancer (for specific cohorts).
- Completed any prior curative chemotherapy, radiotherapy, or chemoradiotherapy at least 6 months before starting study treatment (for specific cohorts).
You will not qualify if you...
- Confirmed microsatellite instability-high (MSI-H) or deficient mismatch repair metastatic colorectal cancer.
- Prior treatment with epithelial cell-adhesion molecule or 4-1BB targeted therapies or immunotherapy.
- Prior treatment with immune checkpoint inhibitors or PD-L1/VEGF bispecific antibodies.
- Eligible for locoregional treatments aimed at complete or near complete response.
- Have uncontrolled or significant cardiovascular disease.
- Left ventricular ejection fraction below 50% within 28 days before enrollment.
- Clinically uncontrolled pleural effusion, ascites, or pericardial effusion requiring drainage within 2 weeks before enrollment.
- Active symptomatic central nervous system metastases or requiring corticosteroid/anticonvulsant therapy.
- Unresolved toxicities from previous anticancer therapy above Grade 1.
- History of unusual toxicity to anticancer therapies or known dihydropyrimidine dehydrogenase deficiency (for Parts B or C).
- History of another primary malignancy within 2 years, except certain treated cancers.
- History of small bowel obstruction requiring hospitalization within past 3 months.
- Significant proteinuria (24-hour urine protein ≥1 g).
- History of autoimmune diseases with risk of exacerbation following PD-L1 inhibition or immune deficiency.
- Serious non-healing wounds, ulcers, or bone fractures, including recent gastrointestinal perforations or fistulas.
- Evidence of major coagulation disorders or significant bleeding risks.
- Other protocol-defined inclusion/exclusion criteria may apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - About 6 to 10 months on average
Participants receive investigational treatments BNT314 and BNT327 in combination with standard chemotherapy. Treatment continues until disease progression, intolerance, or study end.
Regular visits for treatment administration and safety assessments
Duration - Up to 90 days after last dose
Participants are monitored for safety and adverse events after completing treatment.
Several visits for safety monitoring
Duration - Up to 57 months
Participants are followed to monitor overall survival and potential long-term side effects after treatment ends.
Periodic visits for survival and health status monitoring
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
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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