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Precemtabart tocentecan

Phase 3

Metastatic Colorectal Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Aug 14, 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 Sites34

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 StatesAustraliaCanadaChinaJapanSouth KoreaTaiwan
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Competitive Landscape -Colorectal Cancer 258 trials (matched to "Metastatic Colorectal Cancer")

Recent Changes (Last 90 Days)

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

Frequently asked questions about Precemtabart tocentecan

What is Precemtabart tocentecan used for?

Precemtabart tocentecan is an investigational small molecule being studied for the treatment of metastatic colorectal cancer. It is currently in Phase 3 clinical development, specifically for patients with previously treated metastatic colorectal cancer. The drug is being evaluated in combination with or without bevacizumab compared to trifluridine/tipiracil plus bevacizumab.

Who is developing Precemtabart tocentecan?

Precemtabart tocentecan is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting a Phase 3 clinical trial for this drug in patients with metastatic colorectal cancer.

What phase is Precemtabart tocentecan in?

Precemtabart tocentecan is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is actively recruiting participants with previously treated metastatic colorectal cancer.

What clinical trials is Precemtabart tocentecan in?

Precemtabart tocentecan is being studied in a Phase 3 trial with the identifier NCT07549412. The trial is titled '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)'. It is actively recruiting and aims to enroll 1020 participants across multiple countries.

Is Precemtabart tocentecan being tested in a randomized trial?

Yes, Precemtabart tocentecan is being evaluated in a randomized, active-controlled Phase 3 clinical trial. The study compares Precemtabart tocentecan with or without bevacizumab against trifluridine/tipiracil plus bevacizumab in patients with previously treated metastatic colorectal cancer.

Where is the Precemtabart tocentecan clinical trial being conducted?

The Phase 3 clinical trial for Precemtabart tocentecan is being conducted in multiple countries, including the United States, Australia, Canada, China, Japan, South Korea, and Taiwan. The trial is open to adults aged 18 years and older of all sexes.