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M9140

Phase 1

Solid Tumors | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Aug 11, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

M9140 · 1 trial · 2 indications

Phase 1 1
NCT06806046Anti-CEACAM5 ADC Precemtabart Tocentecan (M9140) in Chinese Participants With Solid TumorsSolid Tumors
ACTIVE NOT_RECRUITING12 Analytics
PHASE1ACTIVE NOT_RECRUITING
Anti-CEACAM5 ADC Precemtabart Tocentecan (M9140) in Chinese Participants With Solid Tumors
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Dose Limiting Toxicities (DLTs)
Up to 21 days (Each cycle is of 21 days)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Up to 8 months

Secondary Endpoints

Pharmacokinetic (PK) Plasma Concentrations of M9140
Cycle 1 Day 1 (C1D1) - Predose, 6, 24, 168, 336 hr (hour) post dose: predose C2D1; C3D1 - Predose, 6, 24, 336 hr postdose; C4D1 - predose every 2 cycles until treatment discontinuation (20 months). [Each cycle is of 21 days]
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators
Time from first study treatment throughout the study duration until progressive disease or death up to approximately 8 months
Duration of Response (DoR) According to RECIST v1.1 as Assessed by Investigator
Time from first study treatment throughout the study duration until progressive disease or death up to approximately 8 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
M9140EXPERIMENTAL -

Interventions

NameTypeDescription
M9140DRUGM9140 will be administered every 3 weeks until progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study. There will be 2 dose levels, if the low dose level is tolerated, then M9140 will be escalated to the high dose level.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Participants with documented histopathological diagnosis of locally advanced or metastatic CRC, who were intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage that included and are restricted to a fluoropyrimidine, irinoteca...

Countries:China
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumors")

Recent Changes (Last 90 Days)

LOWAug 11, 2026NCT06806046lastUpdatePostDate: changed
LOWAug 11, 2026NCT06806046lastUpdatePostDate: changed

Frequently asked questions about M9140

What is M9140 used for?

M9140 is an investigational small molecule being studied for the treatment of solid tumors, including colorectal cancer. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does M9140 target?

M9140 is an antibody-drug conjugate (ADC) that targets CEACAM5, a protein expressed on the surface of certain tumor cells. By binding to CEACAM5, the drug aims to deliver a cytotoxic payload directly to cancer cells.

Who makes M9140?

M9140 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy.

What phase is M9140 in?

M9140 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory bodies and is still undergoing clinical trials to assess its safety and potential effectiveness.

What clinical trials is M9140 in?

M9140 is being studied in a Phase 1 clinical trial with the identifier NCT06806046. This trial is evaluating the drug in Chinese participants with solid tumors, including colorectal cancer, and is currently active but not recruiting participants.

Is M9140 the same as Precemtabart Tocentecan?

Yes, M9140 is also known as Precemtabart Tocentecan. The drug is referred to by both names in clinical trial documentation, and they refer to the same investigational antibody-drug conjugate.