ROSETTA CRC-203: A Blinded, Randomized Phase II/III Study of Pumitamig in Combination With Chemotherapy Versus Bevacizumab in Combination With Chemotherapy in Participants With Previously Untreated, Unresectable, or Metastatic Colorectal Cancer
Categories (click each to see list of all clinical trials associated with that category): FPBCC CTO Studies, GI (ONC)
Current Status: Not open
Phase: II/III
Principal Investigator: Tenner, Laura
Contact Information:
Jessica Delaney
jessdelaney@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT07221357?term=NCT07221357&rank=1#participation-criteria
Summary
Phase 2 Primary Objective: To evaluate the OR of pumitamig in combination with FOLFOX/FOLFIRI vs bevacizumab + FOLFOX/FOLFIRI in participants with 1L mCRC.
Secondary Objectives: -To further evaluate the efficacy of pumitamig in combination with FOLFOX/FOLFIRI vs bevacizumab + FOLFOX/FOLFIRI in participants with 1L mCRC. -To inform the dose of pumitamig to continue in Phase 3 of the study.
Phase 3 Primary Objective: To compare PFS of pumitamig in combination with chemotherapy vs bevacizumab + chemotherapy in participants with 1L mCRC.
Secondary Objectives: -To compare OS of pumitamig in combination with chemotherapy vs bevacizumab + chemotherapy in participants with 1L mCRC. -To further evaluate the efficacy of pumitamig in combination with chemotherapy vs bevacizumab + chemotherapy in participants with 1L mCRC.
Exploratory Objectives: To evaluate the safety of pumitamig in combination with chemotherapy vs bevacizumab + chemotherapy in participants with 1L mCRC. -To further evaluate the efficacy of pumitamig in combination with chemotherapy vs bevacizumab + chemotherapy in participants with 1L mCRC. -To evaluate potential candidate biomarkers associated with efficacy and safety outcomes. -To characterize the PK of pumitamig. -To characterize the immunogenicity of pumitamig. -To characterize changes in cancer-related symptoms and QOL. -To evaluate time to deterioration in health-related QOL of pumitamig in combination with chemotherapy vs bevacizumab + chemotherapy in participants with 1L mCRC. -To characterize the impact of the side effects of treatment from the participant's perspective.