> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/anti-ceacam5-adc-m9140-in-advanced-solid-tumors-proceade-crc-17899813-0da8-48b1-83e1-dfd1feafcde6 > Record changed: 2026-10-13 # Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01) NCT05464030 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) Participants 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) Lead sponsor EMD Serono Research & Development Institute, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) Start date 2022-08-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) Number of sites 35 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) ## Title and summary **Summary** The purpose of this first in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2) Study details include: \* Study Duration per participant: Approximately 4 months for Part 1 and 8 months for Part 2 \* M9140 is not available through an expanded access program Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Short title** Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Official title** A Phase I, Multicenter, Open-Label First in Human Study of Anti-CEACAM5 Antibody Drug Conjugate M9140 in Participants With Advanced Solid Tumors (PROCEADE-CRC-01) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) ## Dates **Completion date** 2026-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **First posted** 2022-07-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Registry last updated** 2026-07-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Primary completion date** 2026-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Start date** 2022-08-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) ## Size and sites **Actual participants** 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Participants** 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Protocol amendments** 7 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Number of sites** 35 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Lead sponsor** EMD Serono Research & Development Institute, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) ## Identifiers **Registry ID** NCT05464030 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **ClinicalTrials.gov ID** NCT05464030 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) ## Outcomes ### Primary outcomes 1. Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) Timeframe: up to 4 months 2. Part 1: Recommended Dose Expansion (RDE) of M9140 Timeframe: up to 4 months 3. Parts 2B, 2C and 2D: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) Timeframe: up to 8 months 4. Part 2A: Number of Participants with Adverse Events (AEs) Timeframe: up to 8 months 5. Part 2A: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators Timeframe: Time from first study treatment throughout the study duration until progressive disease or death up to approximately 8 months 6. Part 2A: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators Timeframe: Time from first study treatment to planned assessment at approximately 8 months ### Secondary outcomes 1. Parts 1, 2A, 2B, 2C and 2D: Pharmacokinetic (PK) Plasma Concentrations of M9140 Timeframe: Part 1: Pre-dose up to 4 months; Part 2: Pre-dose up to 8 months 2. Parts 1, 2A, 2B, 2C and 2D: Number of Participants with Anti-Drug Antibodies (ADA) Against M9140 Timeframe: Part 1: up to 4 months; Part 2: up to 8 months 3. Parts 1, 2A, 2B, 2C and 2D: Levels of Titers of Anti-Drug Antibody (ADA) Against M9140 Timeframe: Part 1: up to 4 months; Part 2: up to 8 months 4. Parts 1 and 2A: Number of Participants with Clinically Significant Changes from Baseline in Triplicate 12-Lead Electrocardiogram (ECG) Timeframe: Part 1: up to 4 months; Part 2: up to 8 months 5. Parts 1 and 2A: Change from Baseline in QTc (ΔQTc) Interval Timeframe: Part 1: baseline, up to 4 months; Part 2: baseline up to 8 months 6. Parts 1, 2B, 2C: and 2D: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators Timeframe: Time from first study treatment throughout the study duration until progressive disease or death up to approximately 4 months and 8 months 7. Parts 1, 2B, 2C and 2D: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator Timeframe: Time from first study treatment to planned assessment at approximately 4 months and 8 months 8. Parts 2A, 2B, 2C and 2D: Time to Response Timeframe: Time from first study treatment to planned assessment at approximately 8 months 9. Parts 1, 2A, 2B, 2C and 2D: Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators Timeframe: Time from first study treatment to planned assessment at approximately 4 months and 8 months 10. Part 2A: Overall Survival Timeframe: Time from first study treatment to planned assessment at approximately 8 months 11. Part 2A: Number of Participants with Symptomatic Adverse Events (AEs) Timeframe: up to 8 months 12. Parts 2A, 2B, 2C and 2D: Number of Participants with Disease Control Timeframe: At Week 12 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - Participants with documented histopathological diagnosis of locally advanced or metastatic colorectal cancer (CRC), who were intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage, if locally indicated and available to the participant. Participants with a known microsatellite instability high (MSI-H) status must have received treatment with an immune checkpoint inhibitor (if locally indicated and available) unless contraindicated. - 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 - Other protocol defined inclusion criteria could apply ### Exclusion criteria - Participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years) - Participants with known brain metastases, except those meeting the following criteria: Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment; No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable) - Participants with diarrhea (liquid stool) or ileus Grade > 1 - Participants with active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease, intestinal perforation) and/or bowel obstruction - Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association \[NYHA\] >= II) or a coronary revascularization procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of > 470 milliseconds (ms) - Cerebrovascular accident/stroke (< 6 months prior to enrollment) - Other protocol defined exclusion criteria could apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) ## Sites - California Cancer Associates for Research & Excellence, Inc.Encinitas, United States - California Cancer Associates for Research & Excellence, Inc.Fresno, United States - Rhode Island HospitalProvidence, United States - Mary Crowley Cancer ResearchDallas, United States - MD Anderson Cancer Center - OncologyHouston, United States - NEXT OncologySan Antonio, United States - The Ottawa Hospital Cancer CentreOttawa, Canada - University Health Network - Princess Margaret Cancer CentreToronto, Canada - National Cancer Center Hospital - Dept of GastroenterologyChūōku, Japan - National Cancer Center Hospital EastKashiwa-shi, Japan - Saitama Cancer CenterKitaadachi-gun, Japan - Cancer Institute Hospital of JFCRKōtoku, Japan - Aichi Cancer Center HospitalNagoya, Japan - Kindai University HospitalOsakasayama-shi, Japan - Shizuoka Cancer CenterSunto-gun, Japan - Kanagawa Cancer CenterYokohama, Japan - Kyungpook National University Chilgok HospitalDaegu, South Korea - National Cancer CenterGoyang-si, South Korea - Seoul National University Bundang HospitalSeongnam, South Korea - Asan Medical CenterSeoul, South Korea - Samsung Medical CenterSeoul, South Korea - Seoul National University HospitalSeoul, South Korea - Severance Hospital, Yonsei University Health SystemSeoul, South Korea - Hospital Clinic de BarcelonaBarcelona, Spain - Hospital del MarBarcelona, Spain And 10 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) ## References - PubMed 40739424 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40739424/) Results - PubMed 39754485 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39754485/) Related publication - Related resource (clinicaltrials.emdgroup.com) Source: [clinicaltrials.emdgroup.com](https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS202329%5F0001) - Related resource (medical.emdserono.com) Source: [medical.emdserono.com](https://medical.emdserono.com/en%5FUS/home.html) ### Other registry identifiers (2) - 2022-500508-23-00 - jRCT2031220313 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05464030) ## Related records ### Drugs (5) - [Bevacizumab](https://trialight.com/data/asset/bevacizumab-a9e09d09-2d3c-4fda-ad45-01fd000dd363.md) - [Capecitabine](https://trialight.com/data/asset/capecitabine-a5be3dfa-a85f-4c85-8c62-f4ceb74e5f99.md) - [Fluorouracil](https://trialight.com/data/asset/fluorouracil-f8444d73-5c73-4f35-aa71-67d578277450.md) - [Leucovorin](https://trialight.com/data/asset/leucovorin-8525767e-3f7d-4a78-b2d8-bef4282903ea.md) - [Precemtabart tocentecan](https://trialight.com/data/asset/precemtabart-tocentecan-495d685d-7437-43fd-a725-f1fc70394bbf.md) ### Collaborators (1) - Merck KGaA, Darmstadt, Germany ### Lead sponsors (1) - [EMD Serono Research & Development Institute, Inc.](https://trialight.com/data/company/emd-serono-research-development-institute-inc-e77dadd3-e500-4922-8f75-5f886ee22b12.md) ### Conditions (2) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Primary condition - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) ### Targets (2) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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