NCT06806046Active, not recruitingPhase 1
Anti-CEACAM5 ADC Precemtabart Tocentecan (M9140) in Chinese Participants With Solid Tumors
A Phase 1, Open-label Study of Anti-CEACAM5 Antibody-Drug Conjugate Precemtabart Tocentecan (M9140) in Chinese Participants With Solid Tumors (PROCEADE-CRC-02)
Source: ClinicalTrials.gov · Last updated 11 Aug 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the safety and early clinical activity of M9140 in Chinese participants with locally advanced or metastatic colorectal cancer (CRC).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 13 Jan 2025
- Start date
- Dec 2024
- Primary completion date
- Sept 2026
- Lead sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Diseases
- Colorectal cancer
- NCT number
- NCT06806046
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 12
- From Dec 2024 to the primary completion date, Sept 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Cerebrovascular accident/stroke (\< 6 months prior to enrollment)
Other illness
- 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)
Other
- Participants with diarrhea (liquid stool) or ileus Grade \> 1
- Other protocol defined exclusion criteria could apply
Who the study is looking for
- Participants with documented histopathological diagnosis of locally advanced or metastatic CRC, who were intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage that included and are restricted to a fluoropyrimidine, irinotecan, a platinum agent (e.g. oxaliplatin), an anti-EGFR agent (if clinically indicated, i.e. RAS/BRAF wt), and an anti-VEGF agent. Participants may have received previous treatment with trifluridine/tipiracil and/or regorafenib or fruquintinib, if locally indicated and available. Participants with a known 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| The Sixth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The Second Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.