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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05464030
Recruitment Status : Recruiting
First Posted : July 19, 2022
Last Update Posted : June 17, 2024
Sponsor:
Collaborator:
Merck KGaA, Darmstadt, Germany
Information provided by (Responsible Party):
EMD Serono ( EMD Serono Research & Development Institute, Inc. )

Study Description
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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

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: M9140 Drug: Bevacizumab Drug: Capecitabine Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : August 4, 2022
Estimated Primary Completion Date : February 27, 2026
Estimated Study Completion Date : February 27, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: M9140 Drug: 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.
Experimental: Part 2A: M9140 Drug: M9140
M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative regimen and combination regimen.
Experimental: Part 2B: M9140 Drug: M9140
M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative regimen and combination regimen.
Experimental: Part 2C: M9140 + Bevacizumab +/-Capecitabine Drug: M9140
M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative regimen and combination regimen.

Drug: Bevacizumab
Bevacizumab will be administered intravenously as per standard of care.

Drug: Capecitabine
Capecitabine will be administered orally as per standard of care.


Outcome Measures
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Primary Outcome Measures :
  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 and 2C: 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 Outcome Measures :
  1. Parts 1 and 2: 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 and 2: 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 and 2: 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 and 2C: 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 and 2C: 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 and 2C: Time to Response [ Time Frame: Time from first study treatment to planned assessment at approximately 8 months ]
  9. Parts 1, 2A, 2B and 2C: 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05464030


Contacts
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Contact: US Medical Information 888-275-7376 eMediUSA@emdserono.com
Contact: Communication Center +49 6151 72 5200 service@emdgroup.com

Locations
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United States, Texas
MD Anderson Cancer Center - Oncology Recruiting
Houston, Texas, United States, 77030
Contact       skopetz@mdanderson.org   
Principal Investigator: Scott Kopetz         
NEXT Oncology Recruiting
San Antonio, Texas, United States, 78229
Contact    210-580-9500      
Japan
National Cancer Center Hospital - Dept of Gastroenterology Recruiting
Chuo-ku, Japan
Contact       kenkato@ncc.go.jp   
Principal Investigator: Ken Kato         
Spain
Hospital Clinic de Barcelona Recruiting
Barcelona, Spain
Principal Investigator: Joan Maurel Santasusana         
Hospital Universitari Vall d'Hebron - VHIR Recruiting
Barcelona, Spain
Contact       egarralda@vhio.net   
Principal Investigator: Elena Garralda Cabanas         
Hospital Universitario Quironsalud Madrid - NEXT Oncology Recruiting
Madrid, Spain
Contact       vboni@nextoncology.eu   
Principal Investigator: Valentina Boni         
Sponsors and Collaborators
EMD Serono Research & Development Institute, Inc.
Merck KGaA, Darmstadt, Germany
Investigators
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Study Director: Medical Responsible EMD Serono Research & Development Institute, Inc.
More Information
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Additional Information:

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Responsible Party: EMD Serono Research & Development Institute, Inc.
ClinicalTrials.gov Identifier: NCT05464030    
Other Study ID Numbers: MS202329_0001
2022-500508-23-00 ( Other Identifier: EU CTIS )
First Posted: July 19, 2022    Key Record Dates
Last Update Posted: June 17, 2024
Last Verified: June 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://bit.ly/IPD21

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Bevacizumab
 Capecitabine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action