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M9140

Phase 1

Colorectal Cancer | Small molecule | Oncology |Merck KGaA|Last Updated: Jul 30, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment220

FDA Designations

No designations recorded

Clinical trial landscape

M9140 · 2 trials · 6 indications

Phase 1 2
NCT06710132Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)Solid Tumors
ACTIVE NOT_RECRUITING184 Analytics
NCT05464030Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)Colorectal Cancer
ACTIVE NOT_RECRUITING220 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)
Solid TumorsUnlock trial analytics
PHASE1ACTIVE NOT_RECRUITING
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Substudies GC/NSCLC/PDAC: 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 to (planned) final assessment at approximately 48 months
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)
up to 4 months
Part 1: Recommended Dose Expansion (RDE) of M9140
up to 4 months
Parts 2B, 2C and 2D: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)
up to 8 months
Part 2A: Number of Participants with Adverse Events (AEs)
up to 8 months
Part 2A: 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
Part 2A: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators
Time from first study treatment to planned assessment at approximately 8 months

Secondary Endpoints

Substudies GC/NSCLC/PDAC: Number of Participants with Adverse Events (AEs) and Treatment Related AEs
Time from first study treatment to (planned) final assessment at approximately 48 months
Substudies GC/NSCLC/PDAC: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators
Time from first study treatment to (planned) final assessment at approximately 48 months
Substudies GC/NSCLC/PDAC: Number of Participants with Disease Control
At Week 12
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Substudy GC: M9140 Monotherapy - Part A CEACAM5 HighEXPERIMENTAL -
Substudy GC: M9140 Monotherapy - Part B CEACAM5 LowEXPERIMENTAL -
Substudy NSCLC: M9140 Monotherapy - Part A CEACAM5 High EGFR WtEXPERIMENTAL -
Substudy NSCLC: M9140 Monotherapy - Part B CEACAM5 High EGFR mutEXPERIMENTAL -
Substudy PDAC: M9140 Monotherapy - Part A CEACAM5 HighEXPERIMENTAL -
Part 1: M9140EXPERIMENTAL -
Part 2A: M9140EXPERIMENTAL -
Part 2B: M9140EXPERIMENTAL -
Part 2C: M9140 + Bevacizumab +/-CapecitabineEXPERIMENTAL -
Part 2D: M9140 + 5-fluorouracil + Folinic acid + BevacizumabEXPERIMENTAL -

Interventions

NameTypeDescription
M9140DRUGAll participants will receive 2.8 milligram per kilogram (mg/kg) M9140 intravenously (i.v.) every 3 weeks (q3w) on Day 1 of consecutive 21-day cycles.
BevacizumabDRUGBevacizumab will be administered intravenously as per standard of care.
CapecitabineDRUGCapecitabine will be administered orally as per standard of care.
5-fluorouracil (5-FU)DRUG5-FU will be administered intravenously as per standard of care.
Folinic acidDRUGFolinic acid will be administered intravenously as per standard of care.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites81

Inclusion Criteria: * Participants are capable of signing informed consent as defined in protocol * Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1 * Participants with adequate hematologic, hepatic and renal function as defined in protocol * Participant must have...

Countries:United StatesAustraliaAustriaChinaFranceGermanyItalyJapanSouth KoreaSpainCanada
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Recent Changes (Last 90 Days)

MEDIUMJul 30, 2026NCT05464030Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHJul 30, 2026NCT06710132Enrollment: 250 → 184
MEDIUMJul 30, 2026NCT05464030Status: RECRUITING → ACTIVE_NOT_RECRUITING
HIGHJul 30, 2026NCT06710132Enrollment: 250 → 184

Frequently asked questions about M9140

What is M9140 used for in solid tumors and colorectal cancer?

M9140 is an investigational antibody-drug conjugate being studied for the treatment of advanced solid tumors, including colorectal cancer. It is currently in Phase 1 clinical development for these indications. The drug is being evaluated in patients with colorectal cancer and other advanced solid tumors such as gastric cancer, non-small cell lung cancer, and pancreatic cancer.

What does M9140 target?

M9140 targets CEACAM5, a protein that is overexpressed on the surface of certain cancer cells. As an antibody-drug conjugate, it delivers a cytotoxic payload to CEACAM5-expressing tumor cells. This targeted approach is designed to selectively kill cancer cells while potentially sparing normal tissues.

Who makes M9140?

M9140 is being developed by Merck KGaA, a German multinational pharmaceutical company. The company's stock is traded over-the-counter under the ticker symbol MKGAF. Merck KGaA is conducting clinical trials to evaluate the safety and efficacy of M9140 in patients with advanced solid tumors.

What phase is M9140 in?

M9140 is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trials are designed to assess the safety, tolerability, and preliminary efficacy of M9140 in patients with advanced solid tumors, including colorectal cancer.

What clinical trials is M9140 in?

M9140 is being studied in two active Phase 1 clinical trials. The first trial, NCT05464030, is the PROCEADE-CRC-01 study in patients with colorectal cancer. The second trial, NCT06710132, is the PROCEADE PanTumor study in patients with various advanced solid tumors. Both trials are active but not recruiting participants.

Is M9140 the same as an anti-CEACAM5 ADC?

Yes, M9140 is an anti-CEACAM5 antibody-drug conjugate (ADC). The clinical trial titles refer to it as 'Anti-CEACAM5 ADC M9140'. This means the drug combines an antibody that binds to the CEACAM5 protein with a cytotoxic agent, allowing for targeted delivery of chemotherapy to cancer cells expressing CEACAM5.