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Not recruiting
Phase 1

Anti-CEACAM5 ADC M9140

Sponsor:

EMD Serono Research & Development Institute, Inc.

Code:

NCT05464030

Conditions

Colorectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

M9140

M9140

Bevacizumab

Capecitabine

5-fluorouracil (5-FU)

Study Details

Brief 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

Conditions

Colorectal Cancer

Study ID

NCT05464030

Start date

Aug 4, 2022

Status verified date

Jul, 2026

Completion date

Oct 23, 2026

Anticipated

Primary completion date

Oct 23, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

220 participants

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part 1: M9140

experimental: Part 2A: M9140

experimental: Part 2B: M9140

experimental: Part 2C: M9140 + Bevacizumab +/-Capecitabine

experimental: Part 2D: M9140 + 5-fluorouracil + Folinic acid + Bevacizumab

Interventions

M9140

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.

M9140

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

Bevacizumab

Bevacizumab will be administered intravenously as per standard of care.

Capecitabine

Capecitabine will be administered orally as per standard of care.

5-fluorouracil (5-FU)

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

Folinic acid

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

Primary outcome measure

  • Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) [ Time Frame: up to 4 months ]
  • Part 1: Recommended Dose Expansion (RDE) of M9140 [ Time Frame: up to 4 months ]
  • Parts 2B, 2C and 2D: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) [ Time Frame: up to 8 months ]
  • Part 2A: Number of Participants with Adverse Events (AEs) [ Time Frame: 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 Frame: 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 Frame: Time from first study treatment to planned assessment at approximately 8 months ]

Central Contacts and Locations

More Information

Sponsor

EMD Serono Research & Development Institute, Inc.

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-08. This information was provided to ClinicalTrials.gov by EMD Serono Research & Development Institute, Inc. on 2026-07-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.