A Clinical Trial to Test a New Treatment Combination
Phase 1/2
482
about 5.9 years
18+
4 sites in CT, MI, OH +1
What this study is about
Researchers are testing if a new treatment called BNT314, when combined with another new treatment (BNT327) and chemotherapy, is beneficial and safe for people with advanced colorectal cancer. The trial will enroll adults who have not received any systemic therapy before for their cancer.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive BNT314
- 2.Take BNT327
- 3.Take Bevacizumab
- +2 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
bevacizumab
infusion
Primary: Phase I - Part A: Occurrence of dose interruption or discontinuation of study treatment due to TEAEs, Phase I - Part A: Occurrence of dose limiting toxicities (DLTs) during the DLT observation period, Phase I - Part A: Occurrence of treatment emergent adverse events (TEAEs) and treatment related adverse events (TRAEs), Phase I - Part B: Objective response rate (ORR), Phase I - Part B: Occurrence DLTs during the DLT observation period for the first five participants in each dose cohort, Phase I - Part B: Occurrence of TEAEs and TRAEs, Phase I - Part B: Occurrence of dose interruption or discontinuation of study treatment due to TEAEs, Phase II - Part C: Progression free survival
Secondary: All parts: Duration of response, Phase I - Part A and Part B: Disease control rate, Phase I - Part A and Part B: Geometric mean of pharmacokinetic parameter clearance of BNT314 and BNT327 in serum, Phase I - Part A and Part B: Geometric mean of pharmacokinetic parameter half life of BNT314 and BNT327 in serum, Phase I - Part A and Part B: Geometric mean of pharmacokinetic parameter maximum concentration of BNT314 and BNT327 in serum, Phase I - Part A and Part B: Geometric mean of pharmacokinetic parameter time taken to reach maximum concentration of BNT314 and BNT327 in serum, Phase I - Part A: Geometric mean of pharmacokinetic parameter area under the curve of BNT314 and BNT327 in serum, Phase I - Part A: Geometric mean of pharmacokinetic parameter volume of distribution of BNT314 and BNT327 in serum
Oncology