Metastatic Colorectal CancerPhase 1/2NCT07079631
A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment Pumitamig (BNT327) and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer
A Phase 1/2 study testing BNT314, Pumitamig and SoC chemotherapy treatment 1 in people with Metastatic Colorectal Cancer, run by BioNTech SE at 14 sites in 5 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- BNT314, Pumitamig and SoC chemotherapy treatment 1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 14 sitesin 5 countries
- Study dates
- 18 Jul 2025to Dec 2032
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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 histologically confirmed metastatic colorectal cancer and radiographically documented disease progression after ≥2 prior lines of systemic therapy for metastatic disease as defined in the protocol.
- 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 disease in the neoadjuvant or adjuvant setting are eligible for the study if therapy was completed at least 6 months prior to initiation of study treatment.
- Other cohort-specific inclusion criteria apply.
Who cannot join
- 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 immunotherapy.
- Prior treatment with immune checkpoint inhibitors or programmed death-ligand 1 (PD[L]-1)/vascular endothelial growth factor bispecific antibody.
- Is a candidate to locoregional treatment (including surgical resection, stereotactic radiation therapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as "radical" intent), per investigator's assessment.
- 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 randomization/enrollment.
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- Have clinically uncontrolled pleural effusion, ascites or pericardial effusion requiring drainage, peritoneal shunt, or cell-free concentrated ascites reinfusion therapy within 2 weeks prior to randomization/enrollment.
- Have clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. Participants with untreated, asymptomatic brain metastases for whom local therapy is not indicated per SoC may be eligible if neurologically stable and (if deemed necessary by the investigator). Except for brain metastases history, any participants at imminent risk for spinal cord compression or leptomeningeal disease are not eligible.
- Have unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline toxicities that have resolved with sequelae (e.g., tracheostomy, chronic use of feeding tube, replacement hormones) are allowed, if not associated with increased risk of complications per investigator's assessment.
- Participants in Part B or C who fulfill one of the conditions:
- Prior treatment with anticancer therapies (as defined in the protocol) with unusual toxicity, or
- Known dihydropyrimidine dehydrogenase (DPD) deficiency, testing performed according to the local guidelines. If not tested, lack of DPD activity must be tested for the participants who have not received anticancer therapies (as defined in the protocol) in the prior lines of treatment; testing should be performed according to the local guidelines.
- Have a history of another primary malignancy within 2 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated (adjuvant hormone therapy for malignancies at low risk of relapse is allowed) or have a known additional malignancy that is progressing or requires treatment.
- Have a history of small bowel obstruction requiring hospitalization within the past 3 months prior to the first dose of IMP.
- Have 24-h urine protein excretion ≥1 g. If qualitative urine protein is ≤1+, a 24-h urine protein quantitative test is not required.
- Have active autoimmune disease or a history of autoimmune disease (myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, vasculitis, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, or multiple sclerosis) with a risk of exacerbation following PD-L1 inhibition or have an immune deficiency (allogeneic hematopoietic stem cell transplantation or organ transplantation). Participants with protocol-specified conditions may be eligible.
- Have serious non-healing wounds, ulcers, or bone fractures. This includes history of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess or esophageal and gastric varices, acute gastrointestinal bleeding for which an interval of 6 months must pass before enrollment into this study. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation.
- Have evidence of major coagulation disorders or other significant risks of hemorrhage as specified in the protocol.
- NOTE: Other protocol defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
14 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 5 countries
United States4 sites, 4 recruiting
- Recruiting
Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
Yale University
New Haven, Connecticut, 06511
Spain3 sites, 3 recruiting
- Recruiting
Hospital HM Nou Delfos
Barcelona, 08023
- Recruiting
Vall D'Hebrón Hospital
Barcelona, 08035
- Recruiting
Centro Integral Oncologico Clara Campal
Madrid, 28050
United Kingdom3 sites, 3 recruiting
- Recruiting
Guy's & St Thomas' NHS Foundation Trust, Guy's Hospital
London, SE19RT
- Recruiting
Christie NHS Foundation
Manchester, M20 4BX
- Recruiting
The Royal Marsden NHS
Sutton, SM2 5PT
Germany2 sites, 2 recruiting
- Recruiting
Hämatologisch-Onkologische Praxis Eppendorf - HOPE
Hamburg, 20249
- Recruiting
Asklepios Tumorzentrum Hamburg
Hamburg, 22763
Japan2 sites, 2 recruiting
- Recruiting
National Cancer Center Hospital
Chūōku, 104-0045
- Recruiting
National Cancer Center Hospital East
Kashiwa, 277-8577
About this study
Official title: A Phase I/II, Randomized, Multi-site Trial to Investigate the Efficacy and Safety of BNT314 in Combination With Pumitamig and Chemotherapy in Participants With Metastatic Colorectal Cancer
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).
Read the detailed description
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.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- BNT314, Pumitamig, SoC chemotherapy treatment 1, SoC chemotherapy treatment 2, Bevacizumab
- Keywords
- Microsatellite stable or mismatch repair proficient (MSS/pMMR) tumors, Immune checkpoint inhibitor, Programmed death-ligand 1 (PD-L1), Vascular endothelial growth factor-A (VEGF-A), Bispecific antibody, Immunotherapy, Combination chemotherapy, Dose optimization
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT314Biological
Intravenous (IV) infusion
PumitamigDrug
Also called BNT327, PM8002
IV infusion
SoC chemotherapy treatment 1Drug
IV infusion / IV bolus
SoC chemotherapy treatment 2Drug
IV infusion / IV bolus / oral
BevacizumabDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 (Part A): BNT314 (escalating dose levels) + pumitamig | Experimental | Up to 5 dose levels of BNT314. One or two dose levels of pumitamig. Receives: Biological: BNT314; Drug: Pumitamig |
| Phase 1 (Part B): BNT314 + pumitamig + SoC chemotherapy 1 | Experimental | BNT314 (optimized dose level 1 or 2 as determined based on data from Part A) + pumitamig + SoC combination chemotherapy 1.
One selected dose level of pumitamig. Receives: Biological: BNT314; Drug: Pumitamig; Drug: SoC chemotherapy treatment 1 |
| Phase 1 (Part B): BNT314 + pumitamig + SoC chemotherapy 2 | Experimental | BNT314 (optimized dose level 1 or 2 as determined based on data from Part A) + pumitamig + SoC combination chemotherapy 2.
One selected dose level of pumitamig. Receives: Biological: BNT314; Drug: Pumitamig; Drug: SoC chemotherapy treatment 2 |
| Phase 2 (Part C): BNT314 + pumitamig + SoC chemotherapy 1 | Experimental | Recommended phase 2 dose of BNT314 + pumitamig + SoC combination chemotherapy 1.
One selected dose level of pumitamig. Receives: Biological: BNT314; Drug: Pumitamig; Drug: SoC chemotherapy treatment 1 |
| Phase 2 (Part C): Bevacizumab + SoC chemotherapy 1 | Active comparator | Combination of two different SoC therapies Receives: Drug: SoC chemotherapy treatment 1; Drug: Bevacizumab |
| Phase 2 (Part C): Pumitamig + SoC chemotherapy 1 | Experimental | Pumitamig + SoC combination chemotherapy 1. One selected dose level of pumitamig. Receives: Drug: Pumitamig; Drug: SoC chemotherapy treatment 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I - Part A: Occurrence of dose limiting toxicities (DLTs) during the DLT observation period
Measured: Up to 28 days after Day 1, Cycle 1
Phase I - Part A: Occurrence of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs)
Assessed according to Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) including Grade ≥3, serious, fatal TEAEs by relationship.
Measured: From initiation of the first dose of BNT314 + pumitamig until 90 days after last dose of investigational medicinal product (IMP)
Phase I - Part A: Occurrence of dose interruption or discontinuation of study treatment due to TEAEs
Measured: From initiation of the first dose of BNT314 + pumitamig until 90 days after last dose of IMP
Phase I - Part B: Occurrence DLTs during the DLT observation period for the first five participants in each dose cohort
Measured: Up to 42 days after Day 1, Cycle 1
Phase I - Part B: Occurrence of TEAEs and TRAEs
Assessed according to CTCAE v5.0 including Grade ≥3, serious, fatal TEAEs by relationship.
Measured: From initiation of the first dose of BNT314 + pumitamig + SoC chemotherapy until 90 days after last dose of IMP
Phase I - Part B: Occurrence of dose interruption or discontinuation of study treatment due to TEAEs
Measured: From initiation of the first dose of BNT314 + pumitamig + SoC chemotherapy until 90 days after last dose of IMP
Phase I - Part B: Objective response rate (ORR)
Defined as the percentage of participants in whom a complete response (CR) or confirmed partial response (PR) (assessed by the blinded independent central review [BICR] per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]) is observed as best overall response.
Measured: From the time of initiation of the first dose of IMP to end of study, up to 57 months
Phase II - Part C: Progression free survival
Defined as the time from randomization to first documented tumor progression (progressive disease assessed by BICR per RECIST v1.1), or death from any cause, whichever occurs first.
Measured: From the time of initiation of the first dose of IMP to end of study, up to 57 months
Secondary outcomes (18)
Phase II - Part C: ORR
Defined as the percentage of participants in whom a confirmed CR or PR (assessed by BICR per RECIST v1.1) is observed as best overall response.
Measured: From the time of initiation of the first dose of IMP to end of study, up to 57 months
Phase I - Part A: ORR
Defined as the percentage of participants in whom a confirmed CR or PR (assessed by BICR per RECIST v1.1) is observed as best overall response.
Measured: From the time of initiation of the first dose of IMP to end of study, up to 57 months
All parts: Duration of response
Defined as the time from first objective response (CR or PR assessed by BICR per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease assessed by BICR per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: From the time of initiation of the first dose of IMP to end of study, up to 57 months
Phase I - Part A and Part B: Disease control rate
Defined as the percentage of participants with confirmed CR or PR or stable disease (per RECIST v1.1, assessed at least 6 weeks after the first IMP dose) observed as best ORR per BICR.
Measured: From the time of initiation of the first dose of IMP to end of study, up to 57 months
Phase I - Part A and Part B: Geometric mean of pharmacokinetic parameter maximum concentration of BNT314 and pumitamig in serum.
Per dose level. If data permits.
Measured: From predose to 42 days after first dose of IMP
Phase I - Part A and Part B: Geometric mean of pharmacokinetic parameter time taken to reach maximum concentration of BNT314 and pumitamig in serum.
Per dose level. If data permits.
Measured: From predose to 42 days after first dose of IMP
Phase I - Part A and Part B: Geometric mean of pharmacokinetic parameter half life of BNT314 and pumitamig in serum.
Per dose level. If data permits.
Measured: From predose to 42 days after first dose of IMP
Phase I - Part A: Geometric mean of pharmacokinetic parameter volume of distribution of BNT314 and pumitamig in serum.
Per dose level. If data permits.
Measured: From predose to 42 days after first dose of IMP
Phase I - Part A: Geometric mean of pharmacokinetic parameter area under the curve of BNT314 and pumitamig in serum.
Per dose level. If data permits.
Measured: From predose to 42 days after first dose of IMP
Phase I - Part A and Part B: Geometric mean of pharmacokinetic parameter clearance of BNT314 and pumitamig in serum.
Per dose level. If data permits.
Measured: From predose to 42 days after first dose of IMP
Phase I - Part B: Geometric mean of pharmacokinetic parameter steady state volume of distribution of BNT314 and pumitamig in serum.
Per dose level. If data permits.
Measured: From predose to 42 days after first dose of IMP
Phase I - Part B: Geometric mean of pharmacokinetic parameter total drug exposure across time of BNT314 and pumitamig in serum.
Per dose level. If data permits.
Measured: From predose to 42 days after first dose of IMP
Phase I - Part B: Geometric mean of pharmacokinetic parameter area under the concentration-time curve from pre-dose to last quantifiable time point prior to the next dose of BNT314 and pumitamig in serum.
Per dose level. If data permits.
Measured: From predose to 42 days after first dose of IMP
Phase I - Part A and Part B: ADA prevalence
Percentage of participants who are ADA positive (either baseline or post-baseline). By dose level. If data permits.
Measured: Up to 90 days post last dose of IMP
Phase I - Part A and Part B: Anti-drug antibody (ADA) incidence
Percentage of participants having treatment-emergent ADA. By dose level. If data permits.
Measured: Up to 90 days post last dose of IMP
Phase II - Part C: Overall survival
Defined as the time from randomization to death from any cause
Measured: From the time of initiation of the first dose of IMP to end of study, up to 57 months
Phase II - Part C: Occurrence of TEAEs and TRAEs
Assessed according to CTCAE v5.0 including Grade ≥3, serious, fatal TEAEs by relationship
Measured: From initiation of the first dose of BNT314 + pumitamig until 90 days after last dose of IMP
Phase II - Part C: Occurrence of dose interruption or discontinuation of study treatment due to TEAEs
Measured: From initiation of the first dose of BNT314 + pumitamig until 90 days after last dose of IMP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2025
- Study start18 Jul 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by BioNTech SEThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 482 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genmab
- Responsible party
- Sponsor
- Investigators
- BioNTech Responsible Person, Study director, BioNTech SE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07079631
- Sponsor's protocol ID
- BNT314-02
- Other IDs
- 2025-521768-36-00, IRAS ID: 1012259, CTN: 2025-2539, 2025
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2025
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Randomized, Multi-site Trial to Investigate the Efficacy and Safety of BNT314 in Combination With Pumitamig and Chemotherapy in Participants With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07079631
- Acronym / sponsor ID
- BNT314-02
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Microsatellite stable or mismatch repair proficient (MSS/pMMR) tumors, Immune checkpoint inhibitor, Programmed death-ligand 1 (PD-L1), Vascular endothelial growth factor-A (VEGF-A), Bispecific antibody, Immunotherapy, Combination chemotherapy, Dose optimization
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 482 participants (estimated)
- Lead sponsor
- BioNTech SEIndustry (pharma, biotech, devices)
- Collaborators
- Genmab
- Study start
- 18 Jul 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 23 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Phase 1 (Part A): BNT314 (escalating dose levels) + pumitamig | Experimental | Biological: BNT314, Drug: PumitamigUp to 5 dose levels of BNT314. One or two dose levels of pumitamig. |
| Phase 1 (Part B): BNT314 + pumitamig + SoC chemotherapy 1 | Experimental | Biological: BNT314, Drug: Pumitamig, Drug: SoC chemotherapy treatment 1BNT314 (optimized dose level 1 or 2 as determined based on data from Part A) + pumitamig + SoC combination chemotherapy 1. One selected dose level of pumitamig. |
| Phase 1 (Part B): BNT314 + pumitamig + SoC chemotherapy 2 | Experimental | Biological: BNT314, Drug: Pumitamig, Drug: SoC chemotherapy treatment 2BNT314 (optimized dose level 1 or 2 as determined based on data from Part A) + pumitamig + SoC combination chemotherapy 2. One selected dose level of pumitamig. |
| Phase 2 (Part C): BNT314 + pumitamig + SoC chemotherapy 1 | Experimental | Biological: BNT314, Drug: Pumitamig, Drug: SoC chemotherapy treatment 1Recommended phase 2 dose of BNT314 + pumitamig + SoC combination chemotherapy 1. One selected dose level of pumitamig. |
| Phase 2 (Part C): Bevacizumab + SoC chemotherapy 1 | Active comparator | Drug: SoC chemotherapy treatment 1, Drug: BevacizumabCombination of two different SoC therapies |
| Phase 2 (Part C): Pumitamig + SoC chemotherapy 1 | Experimental | Drug: Pumitamig, Drug: SoC chemotherapy treatment 1Pumitamig + SoC combination chemotherapy 1. One selected dose level of pumitamig. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (19 listed)
- 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 immunotherapy.
- Prior treatment with immune checkpoint inhibitors or programmed death-ligand 1 (PD[L]-1)/vascular endothelial growth factor bispecific antibody.
- Is a candidate to locoregional treatment (including surgical resection, stereotactic radiation therapy or tumor ablation) with potential to induce complete or near complete response and prolonged tumor control (sometimes described as "radical" intent), per investigator's assessment.
- Have uncontrolled or significant cardiovascular disease as specified in the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BNT314Intravenous (IV) infusion | Biological | Phase 1 (Part A): BNT314 (escalating dose levels) + pumitamig, Phase 1 (Part B): BNT314 + pumitamig + SoC chemotherapy 1, Phase 1 (Part B): BNT314 + pumitamig + SoC chemotherapy 2, Phase 2 (Part C): BNT314 + pumitamig + SoC chemotherapy 1 |
| PumitamigAlso: BNT327, PM8002IV infusion | Drug | Phase 1 (Part A): BNT314 (escalating dose levels) + pumitamig, Phase 1 (Part B): BNT314 + pumitamig + SoC chemotherapy 1, Phase 1 (Part B): BNT314 + pumitamig + SoC chemotherapy 2, Phase 2 (Part C): BNT314 + pumitamig + SoC chemotherapy 1, Phase 2 (Part C): Pumitamig + SoC chemotherapy 1 |
| SoC chemotherapy treatment 1IV infusion / IV bolus | Drug | Phase 1 (Part B): BNT314 + pumitamig + SoC chemotherapy 1, Phase 2 (Part C): BNT314 + pumitamig + SoC chemotherapy 1, Phase 2 (Part C): Bevacizumab + SoC chemotherapy 1, Phase 2 (Part C): Pumitamig + SoC chemotherapy 1 |
| SoC chemotherapy treatment 2IV infusion / IV bolus / oral | Drug | Phase 1 (Part B): BNT314 + pumitamig + SoC chemotherapy 2 |
| BevacizumabIV infusion | Drug | Phase 2 (Part C): Bevacizumab + SoC chemotherapy 1 |
Primary outcome
Phase I - Part A: Occurrence of dose limiting toxicities (DLTs) during the DLT observation period
Time frame: Up to 28 days after Day 1, Cycle 1
Phase I - Part A: Occurrence of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs)
Time frame: From initiation of the first dose of BNT314 + pumitamig until 90 days after last dose of investigational medicinal product (IMP)
Assessed according to Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) including Grade ≥3, serious, fatal TEAEs by relationship.
Phase I - Part A: Occurrence of dose interruption or discontinuation of study treatment due to TEAEs
Time frame: From initiation of the first dose of BNT314 + pumitamig until 90 days after last dose of IMP
Phase I - Part B: Occurrence DLTs during the DLT observation period for the first five participants in each dose cohort
Time frame: Up to 42 days after Day 1, Cycle 1
Phase I - Part B: Occurrence of TEAEs and TRAEs
Time frame: From initiation of the first dose of BNT314 + pumitamig + SoC chemotherapy until 90 days after last dose of IMP
Assessed according to CTCAE v5.0 including Grade ≥3, serious, fatal TEAEs by relationship.
Phase I - Part B: Occurrence of dose interruption or discontinuation of study treatment due to TEAEs
Time frame: From initiation of the first dose of BNT314 + pumitamig + SoC chemotherapy until 90 days after last dose of IMP
Phase I - Part B: Objective response rate (ORR)
Time frame: From the time of initiation of the first dose of IMP to end of study, up to 57 months
Defined as the percentage of participants in whom a complete response (CR) or confirmed partial response (PR) (assessed by the blinded independent central review [BICR] per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1]) is observed as best overall response.
Phase II - Part C: Progression free survival
Time frame: From the time of initiation of the first dose of IMP to end of study, up to 57 months
Defined as the time from randomization to first documented tumor progression (progressive disease assessed by BICR per RECIST v1.1), or death from any cause, whichever occurs first.
18 secondary outcomes
Phase II - Part C: ORR
Time frame: From the time of initiation of the first dose of IMP to end of study, up to 57 months
Phase I - Part A: ORR
Time frame: From the time of initiation of the first dose of IMP to end of study, up to 57 months
All parts: Duration of response
Time frame: From the time of initiation of the first dose of IMP to end of study, up to 57 months
Phase I - Part A and Part B: Disease control rate
Time frame: From the time of initiation of the first dose of IMP to end of study, up to 57 months
Phase I - Part A and Part B: Geometric mean of pharmacokinetic parameter maximum concentration of BNT314 and pumitamig in serum.
Time frame: From predose to 42 days after first dose of IMP
Phase I - Part A and Part B: Geometric mean of pharmacokinetic parameter time taken to reach maximum concentration of BNT314 and pumitamig in serum.
Time frame: From predose to 42 days after first dose of IMP
Phase I - Part A and Part B: Geometric mean of pharmacokinetic parameter half life of BNT314 and pumitamig in serum.
Time frame: From predose to 42 days after first dose of IMP
Phase I - Part A: Geometric mean of pharmacokinetic parameter volume of distribution of BNT314 and pumitamig in serum.
Time frame: From predose to 42 days after first dose of IMP
Phase I - Part A: Geometric mean of pharmacokinetic parameter area under the curve of BNT314 and pumitamig in serum.
Time frame: From predose to 42 days after first dose of IMP
Phase I - Part A and Part B: Geometric mean of pharmacokinetic parameter clearance of BNT314 and pumitamig in serum.
Time frame: From predose to 42 days after first dose of IMP
Phase I - Part B: Geometric mean of pharmacokinetic parameter steady state volume of distribution of BNT314 and pumitamig in serum.
Time frame: From predose to 42 days after first dose of IMP
Phase I - Part B: Geometric mean of pharmacokinetic parameter total drug exposure across time of BNT314 and pumitamig in serum.
Time frame: From predose to 42 days after first dose of IMP
Phase I - Part B: Geometric mean of pharmacokinetic parameter area under the concentration-time curve from pre-dose to last quantifiable time point prior to the next dose of BNT314 and pumitamig in serum.
Time frame: From predose to 42 days after first dose of IMP
Phase I - Part A and Part B: ADA prevalence
Time frame: Up to 90 days post last dose of IMP
Phase I - Part A and Part B: Anti-drug antibody (ADA) incidence
Time frame: Up to 90 days post last dose of IMP
Phase II - Part C: Overall survival
Time frame: From the time of initiation of the first dose of IMP to end of study, up to 57 months
Phase II - Part C: Occurrence of TEAEs and TRAEs
Time frame: From initiation of the first dose of BNT314 + pumitamig until 90 days after last dose of IMP
Phase II - Part C: Occurrence of dose interruption or discontinuation of study treatment due to TEAEs
Time frame: From initiation of the first dose of BNT314 + pumitamig until 90 days after last dose of IMP
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
BioNTech Responsible Person study director
BioNTech SE
14 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BNT314, Pumitamig and SoC chemotherapy treatment 1 in people with Metastatic Colorectal Cancer, run by BioNTech SE at 14 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Spain, United Kingdom, Germany, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BioNTech clinical trials patient information (+49 6131 9084 ext. 0, patients@biontech.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I - Part A: Occurrence of dose limiting toxicities (DLTs) during the DLT observation period (time frame: Up to 28 days after Day 1, Cycle 1). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.