BridgeMD
New treatment option for Metastatic Colorectal Cancer
Official title 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
ClinicalTrials.gov ID: NCT07079631
What this study is testing
What is BNT314?
BNT314 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- Have Eastern Cooperative Oncology Group Performance Status of 0 or 1.
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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. 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...
- 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...
- 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.
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Grand Rapids, Michigan, United States
- Cleveland, Ohio, United States
- Houston, Texas, United States
- Hamburg, Germany
- Chūōku, Japan
- Kashiwa, Japan
- Barcelona, Spain
- Madrid, Spain
- London, United Kingdom
- Manchester, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Grand Rapids, Michigan, United States; Cleveland, Ohio, United States; Houston, Texas, United States; Hamburg, Germany; Chūōku, Japan and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.