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Colorectal CancerPhase 1NCT05464030

Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)

A Phase 1 study testing M9140, Bevacizumab and Capecitabine in people with Colorectal Cancer, run by EMD Serono Research & Development Institute, Inc. at 35 sites in 5 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
M9140, Bevacizumab and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
35 sitesin 5 countries
Study dates
4 Aug 2022to 23 Oct 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

35 sites in 5 countries.

35 sites in 5 countries

Spain12 sites

  • Hospital Clinic de Barcelona

    Barcelona

  • Hospital del Mar

    Barcelona

  • Hospital HM Nou Delfos

    Barcelona

  • Hospital Universitari Vall d'Hebron - VHIR

    Barcelona

  • Hospital Universitario Reina Sofia

    Córdoba

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat

  • Centro Integral Oncologico Clara Campal

    Madrid

  • Hospital Universitario 12 de Octubre

    Madrid

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid

  • Hospital Universitario Quironsalud Madrid - NEXT Oncology

    Madrid

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela

  • Hospital Universitario Virgen del Rocio

    Seville

Other trials in Spain

Japan8 sites

  • National Cancer Center Hospital - Dept of Gastroenterology

    Chūōku

  • National Cancer Center Hospital East

    Kashiwa-shi

  • Saitama Cancer Center

    Kitaadachi-gun

  • Cancer Institute Hospital of JFCR

    Kōtoku

  • Aichi Cancer Center Hospital

    Nagoya

  • Kindai University Hospital

    Osakasayama-shi

  • Shizuoka Cancer Center

    Sunto-gun

  • Kanagawa Cancer Center

    Yokohama

Other trials in Japan

South Korea7 sites

  • Kyungpook National University Chilgok Hospital

    Daegu

  • National Cancer Center

    Goyang-si

  • Seoul National University Bundang Hospital

    Seongnam

  • Asan Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital, Yonsei University Health System

    Seoul

Other trials in South Korea

United States6 sites

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • California Cancer Associates for Research & Excellence, Inc.

    Encinitas, California, 92024

  • California Cancer Associates for Research & Excellence, Inc.

    Fresno, California, 93720

  • MD Anderson Cancer Center - Oncology

    Houston, Texas, 77030

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • NEXT Oncology

    San Antonio, Texas, 78229

Other trials in United States

Canada2 sites

  • The Ottawa Hospital Cancer Centre

    Ottawa

  • University Health Network - Princess Margaret Cancer Centre

    Toronto

Other trials in Canada

About this study

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)

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
Being tested
M9140, Bevacizumab, Capecitabine, 5-fluorouracil (5-FU), Folinic acid
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • M9140Drug

    Also called Precemtabart tocentecan

    M9140 will be administered at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose for Expansion (RDE) is determined in Part 1 of the study.

  • M9140Drug

    Also called Precemtabart tocentecan

    M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen.

  • BevacizumabDrug

    Bevacizumab will be administered intravenously as per standard of care.

  • CapecitabineDrug

    Capecitabine will be administered orally as per standard of care.

  • 5-fluorouracil (5-FU)Drug

    5-FU will be administered intravenously as per standard of care.

  • Folinic acidDrug

    Folinic acid will be administered intravenously as per standard of care.

Study groups in NCT05464030
Study groupRoleWhat they receive
Part 1: M9140ExperimentalNot described
Receives: Drug: M9140
Part 2A: M9140ExperimentalNot described
Receives: Drug: M9140
Part 2B: M9140ExperimentalNot described
Receives: Drug: M9140
Part 2C: M9140 + Bevacizumab +/-CapecitabineExperimentalNot described
Receives: Drug: M9140; Drug: Bevacizumab; Drug: Capecitabine
Part 2D: M9140 + 5-fluorouracil + Folinic acid + BevacizumabExperimentalNot described
Receives: Drug: M9140; Drug: 5-fluorouracil (5-FU); Drug: Folinic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)

    Measured: up to 4 months

  2. Part 1: Recommended Dose Expansion (RDE) of M9140

    Measured: up to 4 months

  3. Parts 2B, 2C and 2D: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)

    Measured: up to 8 months

  4. Part 2A: Number of Participants with Adverse Events (AEs)

    Measured: 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

    Measured: 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

    Measured: Time from first study treatment to planned assessment at approximately 8 months

Secondary outcomes (12)

  1. Parts 1, 2A, 2B, 2C and 2D: Pharmacokinetic (PK) Plasma Concentrations of M9140

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: Part 1: up to 4 months; Part 2: up to 8 months

  5. Parts 1 and 2A: Change from Baseline in QTc (ΔQTc) Interval

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Time from first study treatment to planned assessment at approximately 4 months and 8 months

  10. Part 2A: Overall Survival

    Measured: Time from first study treatment to planned assessment at approximately 8 months

  11. Part 2A: Number of Participants with Symptomatic Adverse Events (AEs)

    Measured: up to 8 months

  12. Parts 2A, 2B, 2C and 2D: Number of Participants with Disease Control

    Measured: At Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2022
  2. Study start4 Aug 2022
  3. Primary completion23 Oct 2026 (estimated)
  4. Study completion23 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05464030
Sponsor's protocol ID
MS202329_0001
Other IDs
2022-500508-23-00, jRCT2031220313
Status last verified
Jul 2026
First submitted
15 Jul 2022
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21

Publications

  • Kopetz S, Boni V, Kato K, Raghav KPS, Vieito M, Pallis A, Habermehl C, Siddiqui A, Courlet P, Sloot W, Raab-Westphal S, Hart F, Rodriguez-Rivera I. Precemtabart tocentecan, an anti-CEACAM5 antibody-drug conjugate, in metastatic colorectal cancer: a phase 1 trial. Nat Med. 2025 Oct;31(10):3504-3513. doi: 10.1038/s41591-025-03843-z. Epub 2025 Jul 30.

    PubMed 40739424

  • Sloot WN, Bertotti E, Onidi M, Paoletti A, Salve I, Tavano P, Vigna E, Mueller G. The Nonclinical Safety Assessment of a Novel Anti-CEACAM5 Antibody Exatecan Conjugate Predicts a Low Risk for Interstitial Lung Disease (ILD) in Patients-The Putative Mechanism Behind ILD. Int J Toxicol. 2025 Mar-Apr;44(2):153-169. doi: 10.1177/10915818241306039. Epub 2025 Jan 4.

    PubMed 39754485

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing M9140, Bevacizumab and Capecitabine in people with Colorectal Cancer, run by EMD Serono Research & Development Institute, Inc. at 35 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Spain, Japan, South Korea, United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) (time frame: up to 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05464030, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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