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

NCT05464030
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Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
220
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Lead sponsor
EMD Serono Research & Development Institute, Inc.
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Start date
2022-08-04
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Number of sites
35
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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
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Short title
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
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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)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2026-10-23
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First posted
2022-07-19
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Registry last updated
2026-07-30
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Primary completion date
2026-10-23
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Start date
2022-08-04
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Actual participants
220
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Participants
220
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Participant count basis
Actual
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Protocol amendments
7
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Number of sites
35
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
EMD Serono Research & Development Institute, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05464030
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ClinicalTrials.gov ID
NCT05464030
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  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

  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
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • 2022-500508-23-00
  • jRCT2031220313
Sources for references
clinicaltrials.gov

Related records

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Collaborators (1)

Lead sponsors (1)

Conditions (2)

Targets (2)