This study aims to address the unmet medical need of participants with metastatic colorectal cancer (mCRC) who have previously been treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, by demonstrating an overall survival prolongation with precemtabart tocentecan (Precem-TcT) as single agent or Precem-TcT in combination with bevacizumab compared to trifluoride/tipiracil (FTD-TPI) plus bevacizumab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,020
Precem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.
Bevacizumab, administered intravenously every 3 weeks on Day 1 of each 21-day cycle or every 2 weeks on Day 1 and Day 15 of each 28-day cycle.
FTD-TPI, tablet, administered orally twice daily, on Days 1 to 5 and Days 8 to 12 of each 28-day cycle.
Rocky Mountain Cancer Centers, LLP- Aurora
Lone Tree, Colorado, United States
RECRUITINGFlorida Cancer Specialists-Broadway
Fort Myers, Florida, United States
RECRUITINGFlorida Cancer Specialists - St. Petersburg Bayfront
St. Petersburg, Florida, United States
RECRUITINGFlorida Cancer Specialists East - FCS EAST - West Palm Beach
West Palm Beach, Florida, United States
Arm 1, 2 and 3: Overall Survival
Time frame: Time from date of randomization to death, assessed approximately up to average of 19 months
Arm 1 and Arm 2: Overall Survival
Time frame: Time from date of randomization to death, assessed approximately up to average of 19 months
Progression Free Survival (PFS)
Time frame: Time from randomization to the first occurrence of disease progression or death, whichever occurs first (assessed up to average of 19 months)
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
Time frame: Up to average of 19 months
Duration of Response as Assessed by Investigator
Time frame: Time from first documentation of objective response to PD or death (assessed up to average of 19 months)
Number of Participants with Adverse Events (AEs) and Treatment Related Adverse Events
Time frame: Up to average of 19 months
Observed Concentration at End of Infusion (CEOI) Period
Time frame: At end of infusion on Cycle 1 Day 1 and Cycle 3 Day 1 (Arm 1 and Arm 2 only; each cycle is for 21 days)
Concentration Observed at the end of a Dosing Interval Immediately Before next Dosing (Ctrough)
Time frame: At end of dosing interval on Cycle1Day1,Cycle2Day1,Cycle3Day1,Cycle4Day1, Cycle5Day1,Cycle6Day1,Cycle7Day1 until treatment discontinuation(assessed up to average of 19months (Arm 1 and Arm 2 only; each cycle is for 21 days)
Number of Participants with Anti-Drug Antibody as measured by ADA assay
Time frame: Predose(-4to0 hours)on Cycle1Day1,Cycle2 Day1,Cycle 3Day1,Cycle4Day1, Cycle8Day1;thereafter every 4cycles until treatment discontinuation(assessed up to average of 19 months) (Arm 1 and Arm 2 only; each cycle is for 21 days)
Change from Baseline in Global Health Status, Physical, and Role Functioning Subscale Scores of European Organization for research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30)
EORTC QLQ-C30 is a 30-question tool used to assess the overall quality of life (QoL) in cancer participants. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, role, cognitive, emotional, social), and 9 symptom scales/items (Fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, financial impact. The EORTC QLQ-C30 GHS/QoL score ranges from 0 to 100; High score indicates better GHS/QoL. Score 0 represents: very poor physical condition and QoL. Score 100 represents: excellent overall physical condition and QoL.
Time frame: Baseline, Cycle 1 Day 1 and Day 1 of every new cycle until treatment discontinuation (assessed up to average of 19 months).
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Illinois Cancer Specialists
Arlington Heights, Illinois, United States
RECRUITINGIllinois CancerCare PC
Peoria, Illinois, United States
RECRUITINGSpringfield Clinic
Springfield, Illinois, United States
RECRUITINGProfound Research LLC at Cancer and Leukemia Center
Sterling Heights, Michigan, United States
RECRUITINGMinnesota Oncology Hematology, P.A.
Saint Louis Park, Minnesota, United States
RECRUITINGMissouri Cancer Associates - 150518964
Columbia, Missouri, United States
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