Study on New Treatments BNT314 and BNT327 with Chemotherapy for Advanced Colorectal Cancer

Sponsor: BioNTech SE

Sponsor score: 0

ClinicalTrials ID:NCT07079631

Provider View

This clinical trial is testing a new treatment combination involving BNT314 and BNT327, along with chemotherapy, to see if it is safe and effective for patients with advanced colorectal cancer that has spread and not responded well to initial treatments.

Patient Parameters

Program Overview

This study is exploring a new treatment approach for patients with advanced colorectal cancer that has spread (metastatic colorectal cancer or mCRC). The treatment involves two new drugs, BNT314 and BNT327, which are designed to help the immune system fight cancer, used together with standard chemotherapy. The study will include patients whose cancer is stable at the genetic level (MSS/pMMR) and who did not respond well to their first chemotherapy treatment. In one part of the study, patients who have not received any previous systemic therapy for their cancer will be included.

Description

The study has three main parts:

  • Part A (Phase 1, Safety Run-In): This part will test if the combination of BNT314 and BNT327 is safe for patients and determine the highest dose that can be given without causing severe side effects.
  • Part B (Phase 1, Dose Optimization): This part will find the best dose of BNT314 to use with BNT327 and standard chemotherapy, ensuring it is safe for patients.
  • Part C (Phase 2, Randomization): This part will compare the new treatment combination with the usual chemotherapy to see if it can shrink tumors or slow their growth.

The study includes a screening period, a treatment period, a safety follow-up period, and a long-term follow-up period to monitor survival and any long-term side effects. Participants will continue treatment until their cancer worsens, they cannot tolerate the treatment, or the study ends. They are expected to be on treatment for about 6-10 months on average. After treatment, they will be monitored for survival and any potential long-term side effects.

Eligibility Criteria

Inclusion Criteria

  • Have advanced colorectal cancer that cannot be removed by surgery.
  • Have cancer that is stable at the genetic level (MSS/pMMR) as confirmed by approved tests.
  • Have measurable cancer as defined by standard criteria.
  • Provide a tumor sample for testing, preferably a recent one.
  • Be in good overall health with a performance status of 0 or 1.
  • Have a life expectancy of at least 12 weeks.
  • Have adequate organ and bone marrow function.
  • Have had a sufficient break from previous treatments before starting the study.

Additional criteria for specific groups:

  • Have received at least two previous treatments for metastatic cancer.
  • Have cancer that progressed after first-line chemotherapy.
  • Have not received prior systemic therapy for MSS/pMMR mCRC, except for certain treatments completed at least 6 months before the study.

Exclusion Criteria

  • Have a type of colorectal cancer with high genetic instability (MSI-H).
  • Have had certain previous cancer treatments targeting specific proteins or immune checkpoints.
  • Be eligible for treatments that could completely or nearly completely remove the cancer.
  • Have uncontrolled heart disease or other significant health issues.
  • Have certain fluid buildups in the body that require frequent drainage.
  • Have active or untreated brain metastases.
  • Have unresolved side effects from previous cancer treatments.
  • Have a history of another cancer within the past 2 years, except for certain non-threatening cancers.
  • Have a history of bowel obstruction requiring hospitalization recently.
  • Have certain autoimmune diseases or immune deficiencies.
  • Have serious non-healing wounds or significant bleeding risks.

Note: Other specific criteria may apply.

Locations

FACILITYZIPCITYSTATE
START Midwest49546Grand RapidsMichigan
Cleveland Clinic Taussig Cancer Institute Case Comprehensive Cancer Center44195ClevelandOhio
The University of Texas MD Anderson Cancer Center77030HoustonTexas

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