At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- BNT314 (biological), Pumitamig (drug), SoC chemotherapy treatment 1 (drug), SoC chemotherapy treatment 2 (drug)
- How long the study runs
- Study runs about 89 months (dates as stated)
- About the drug or intervention
- BNT314 — biological: Intravenous (IV) infusion · Pumitamig — drug: IV infusion · SoC chemotherapy treatment 1 — drug: IV infusion / IV bolus · SoC chemotherapy treatment 2 — drug: IV infusion / IV bolus / oral · Bevacizumab — drug: IV infusion
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is looking at whether an experimental treatment called BNT314, combined with another experimental treatment called pumitamig (BNT327) and chemotherapy, is helpful and safe for people with advanced bowel (colorectal) cancer that has spread to other parts of the body. The study is run by BioNTech SE.
Who can take part
- Have bowel or rectal cancer (a type called adenocarcinoma) that cannot be removed by surgery and has spread
- Have a type of tumour known as non-MSI-H or pMMR (tested using an approved test)
- Have cancer that can be measured on scans
- Can provide a tumour tissue sample (a recent one is preferred, but an older sample less than 2 years old may be accepted)
- Are well enough to carry out light activity (performance status 0 or 1)
- Are expected to live at least 12 weeks
- Have healthy enough organs and bone marrow, checked within 7 days before starting
- Depending on the study part: may have had at least 2 previous courses of treatment, have got worse after first-line chemotherapy, or have not had any previous whole-body treatment for this type of metastatic cancer (some earlier treatment with curative intent may be allowed if finished at least 6 months before)
Who may not be able to
- Have the MSI-H or deficient mismatch repair type of bowel cancer
- Have had treatments targeting EpCAM or 4-1BB, immune checkpoint inhibitors, or PD(L)-1/VEGF bispecific antibodies
- Could have treatment aiming to remove or destroy the cancer (such as surgery, targeted radiotherapy or ablation)
- Have uncontrolled or significant heart disease, or heart pumping strength below 50%
- Have fluid build-up around the lungs, abdomen or heart that needs draining
- Have active cancer spread to the brain that is causing symptoms or needs steroids or seizure medicines (some treated or symptom-free cases may still join)
- Have ongoing side effects from previous cancer treatment (except hair loss) that have not settled to a mild level
- For some parts of the study: unusual reactions to previous cancer drugs, or a known DPD (dihydropyrimidine dehydrogenase) deficiency
- Have had another cancer in the past 2 years, apart from certain fully treated cases
- Have had a blocked small bowel needing hospital care in the past 3 months
- Lose 1 gram or more of protein in their urine over 24 hours
- Have an active autoimmune disease (such as lupus, rheumatoid arthritis, inflammatory bowel disease or multiple sclerosis) or a weakened immune system (such as an organ transplant)
- Have wounds, ulcers or bone fractures that are not healing, or a history of fistula, bowel perforation, abscess or bleeding in the gut within the past 6 months
- Have serious blood clotting problems or a high risk of serious bleeding
What taking part involves
- • BNT314, an investigational (experimental) treatment
- • Pumitamig (BNT327), another investigational treatment
- • Chemotherapy
- • The study has different parts (including Part B and Part C) with different groups of patients
Time commitment: Not stated — ask the trial team
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 482
- Started
- 2025-07-18
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for metastatic colorectal cancer
- • Phase1/Phase2 - 482 participants
- • This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's own defense to fight cancer in combination with another new treatment (pumitamig, which is a cancer immunotherapy drug also known as BNT327 and PM8002) and chemotherapy in participants with metastatic colorectal cancer (mCRC)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with metastatic colorectal cancer
Where?
- • London - Guy's & St Thomas' NHS Foundation Trust, Guy's Hospital
- • Manchester - Christie NHS Foundation
- • Sutton - The Royal Marsden NHS
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's own defense to fight cancer in combination with another new treatment (pumitamig, which is a cancer immunotherapy drug also known as BNT327 and PM8002) and chemotherapy in participants with metastatic colorectal cancer (mCRC).
More detail
Participants with microsatellite stable or mismatch repair proficient (MSS/pMMR) mCRC with progressive disease to the metastatic first line (1L) setting (Parts B and C) and beyond (Part A) as well as treatment-naïve (for Part B) are eligible to participate in the study. The main study goals are as follows: * Part A (Phase 1, safety run-in, dose escalation): To see if BNT314 in combination with pumitamig can be given safely, without causing severe side effects in participants. * Part B (Phase 1, dose optimization): To see if BNT314 in combination with pumitamig and standard of care (SoC) chemotherapy is safe for participants and to find out the right dose of BNT314 that can be used in Part C. * Part C (Phase 2, randomization against SoC): To see how well treatment works when BNT314 and pumitamig are given in combination with the usual SoC chemotherapy treatment. In all three parts, the study will also look whether BNT314 can shrink tumors or slow down their growth when used with pumitamig and chemotherapy. The study consists of a period to assess eligibility, a treatment period, a safety follow-up period, and a long-term survival follow-up period. The sponsor plans to proactively assess participant safety on a regular basis for the duration of the study according to a predefined internal review committee. In addition, an independent data monitoring committee will be developed to provide medical oversight over Part C of the study. Participants in the study will continue to receive treatment until their disease worsens, they can no longer tolerate the treatment, the participant chooses to leave the study, or the study ends. They are expected to be on treatment for about of 6-10 months on average. Participants may stop treatment early if their disease worsens or side effects occur but can continue longer if the disease stays controlled and the therapy is well-tolerated. After that, they will be monitored for their survival and any potential long-term side effects even after they stop participating in the study. Participants will be randomized to the treatment groups in Part B and Part C, which means participants will be assigned by equal chance to a treatment group.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ washout period bef
What the study is looking for
- ✓Have unresectable confirmed by a biopsy adenocarcinoma of the colon or rectum.
- ✓Have confirmed non-microsatellite instability-high (non-MSI-H)/pMMR mCRC per Food and Drug Administration...
- ✓Have cancer that can be measured on scans defined by (standard scan measurements).
- ✓Have activity scale Performance Status of 0 or 1.
- ✓Have a life expectancy of ≥12 weeks.
Who cannot take part
- ✗Confirmed MSI-H/deficient mismatch repair mCRC (per FDA/CE approved test or based on local testing).
- ✗Prior treatment with epithelial cell-adhesion molecule or 4-1BB targeted or treatment that helps your immune system fight cancer.
- ✗Prior treatment with immune checkpoint inhibitors or programmed death-ligand 1 (PD\[L\]-1)/vascular endothelial...
- ✗Have uncontrolled or significant cardiovascular disease as specified in the protocol.
- ✗Have left ventricular ejection fraction \<50% by echocardiogram or multigated acquisition within 28 days before...
See the full criteria
Where Is This Study? (3 UK sites)
Guy's & St Thomas' NHS Foundation Trust, Guy's Hospital
London SE19RT, United Kingdom
Christie NHS Foundation
Manchester M20 4BX, United Kingdom
The Royal Marsden NHS
Sutton SM2 5PT, United Kingdom
How to Get in Touch
BioNTech clinical trials patient information
Sponsor contactCONTACT
