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NCT Number: NCT05464030

Anti-CEACAM5 ADC M9140 in 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Ottawa Hospital Cancer Centre, Ottawa, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

M9140

Drug

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.

Other names: Precemtabart tocentecan

Bevacizumab

Drug

Bevacizumab will be administered intravenously as per standard of care.

Capecitabine

Drug

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 acid

Drug

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

Primary outcomes

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

    Time frame: up to 4 months

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

    Time frame: up to 4 months

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

    Time frame: up to 8 months

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: Part 1: up to 4 months; Part 2: up to 8 months

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

  10. Part 2A: Overall Survival

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

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

    Time frame: up to 8 months

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

    Time frame: At Week 12

Sponsors and collaborators

Lead sponsor

EMD Serono Research & Development Institute, Inc.

Industry

Collaborators

  • Merck KGaA, Darmstadt, Germany

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 19, 2022
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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