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Precemtabart tocentecan

Phase 3

Metastatic Colorectal Cancer | Small molecule | Oncology |Merck KGaA|Last Updated: Sep 9, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment1,020

FDA Designations

No designations recorded

Clinical trial landscape

Precemtabart tocentecan · 1 trial · 1 indication

Phase 3 1
NCT07549412A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)Metastatic Colorectal Cancer
RECRUITING1,020 Analytics
PHASE3RECRUITING
A Study of Precemtabart Tocentecan With or Without Bevacizumab Compared to Trifluridine/Tipiracil Plus Bevacizumab in Participants With Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)
Metastatic Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Arm 1, 2 and 3: Overall Survival
Time from date of randomization to death, assessed approximately up to average of 19 months

Secondary Endpoints

Arm 1 and Arm 2: Overall Survival
Time from date of randomization to death, assessed approximately up to average of 19 months
Progression Free Survival (PFS)
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
Up to average of 19 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1: Precemtabart tocentecan (Precem-TcT) MonotherapyEXPERIMENTAL -
Arm 2: Precem-TcT plus BevacizumabEXPERIMENTAL -
Arm 3: Trifluridine/Tipiracil (FTD-TPI) plus BevacizumabACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Precemtabart tocentecanDRUGPrecem-TcT, administered, once every 3 weeks intravenously, on Day 1 of each 21-day cycle.
BevacizumabDRUGBevacizumab, 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.
Trifluridine/Tipiracil (FTD-TPI)DRUGFTD-TPI, tablet, administered orally twice daily, on Days 1 to 5 and Days 8 to 12 of each 28-day cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites66

Inclusion Criteria: * Participants with documented histopathological diagnosis of metastatic colorectal cancer, who were intolerant to, or whose disease was refractory to, or progressed after standard systemic therapies and no more than 2 previous systemic treatment regimens in the metastatic setti...

Countries:United StatesArgentinaAustraliaAustriaBelgiumCanadaChinaFranceGermanyHong KongJapanPolandSouth KoreaSpainTaiwanUnited Kingdom
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Competitive Landscape -Colorectal Cancer 257 trials (matched to "Metastatic Colorectal Cancer")

Recent Changes (Last 90 Days)

LOWSep 9, 2026NCT07549412lastUpdatePostDate: changed
LOWSep 9, 2026NCT07549412lastUpdatePostDate: changed
LOWAug 14, 2026NCT07549412lastUpdatePostDate: changed
LOWAug 14, 2026NCT07549412lastUpdatePostDate: changed
LOWJul 24, 2026NCT07549412lastUpdatePostDate: changed
LOWJul 24, 2026NCT07549412lastUpdatePostDate: changed