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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) (Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors)

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

Uemura Chie

Merck Biopharma Co., Ltd.

1-3-1 Azabudai, Minato-ku, Tokyo

MBJ_clinicaltrial_information@merckgroup.com

Contact for Clinical Trial Information

Merck Biopharma Co., Ltd.

1-3-1 Azabudai, Minato-ku, Tokyo

+81-3-6756-0800

MBJ_clinicaltrial_information@merckgroup.com

Not Recruiting

Sept. 15, 2022

Interventional

randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

- 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

Both

Colorectal Cancer

[M9140]
- Part 1: 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.
- Part 2 : Dose Optimization
- Part 2A: M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen.
- Part 2B : M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen.
- Part 2C: M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen. Bevacizumab will be administered intravenously as per standard of care. Capecitabine will be administered orally as per standard of care.
- Part 2D: M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen. 5-FU will be administered intravenously as per standard of care. Folinic acid will be administered intravenously as per standard of care.

Part 1
- Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) [ Time Frame: up to 4 months ]
- Recommended Dose Expansion (RDE) of M9140 [ Time Frame: up to 4 months ]
Part 2
Part 2A: Number of Participants with Adverse Events (AEs)[Time Frame: up to 8 months], 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], and 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]
Parts 2B, 2C and 2D: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) [Time Frame: up to 8 months]

+81-3-3542-2511

Aug. 29, 2022

No

Spain/USA/South Korea/Canada