Colorectal Cancer Clinical Trials

Find Colorectal Cancer Clinical Trials Near You

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

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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 metastatic colorectal cancer (mCRC).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

• 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.

• 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.

Locations
United States
Connecticut
Yale University
RECRUITING
New Haven
Michigan
START Midwest
RECRUITING
Grand Rapids
Ohio
Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center
RECRUITING
Cleveland
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Other Locations
Germany
Asklepios Tumorzentrum Hamburg
RECRUITING
Hamburg
Hämatologisch-Onkologische Praxis Eppendorf - HOPE
RECRUITING
Hamburg
Japan
National Cancer Center Hospital
RECRUITING
Chūōku
National Cancer Center Hospital East
RECRUITING
Kashiwa
Spain
Hospital HM Nou Delfos
RECRUITING
Barcelona
Vall D'Hebrón Hospital
RECRUITING
Barcelona
Centro Integral Oncologico Clara Campal
RECRUITING
Madrid
United Kingdom
Guy's & St Thomas' NHS Foundation Trust, Guy's Hospital
RECRUITING
London
Christie NHS Foundation
RECRUITING
Manchester
The Royal Marsden NHS
RECRUITING
Sutton
Contact Information
Primary
BioNTech clinical trials patient information
patients@biontech.de
+49 6131 9084
Time Frame
Start Date: 2025-07-18
Estimated Completion Date: 2032-12
Participants
Target number of participants: 482
Treatments
Experimental: Phase 1 (Part A): BNT314 (escalating dose levels) + pumitamig
Up to 5 dose levels of BNT314. One or two dose levels of pumitamig.
Experimental: Phase 1 (Part B): BNT314 + pumitamig + SoC chemotherapy 1
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.
Experimental: Phase 1 (Part B): BNT314 + pumitamig + SoC chemotherapy 2
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.
Experimental: Phase 2 (Part C): BNT314 + pumitamig + SoC chemotherapy 1
Recommended phase 2 dose of BNT314 + pumitamig + SoC combination chemotherapy 1.~One selected dose level of pumitamig.
Active_comparator: Phase 2 (Part C): Bevacizumab + SoC chemotherapy 1
Combination of two different SoC therapies
Experimental: Phase 2 (Part C): Pumitamig + SoC chemotherapy 1
Pumitamig + SoC combination chemotherapy 1. One selected dose level of pumitamig.
Related Therapeutic Areas
Sponsors
Collaborators: Genmab
Leads: BioNTech SE

This content was sourced from clinicaltrials.gov