Clinical Trials in South Korea / NCT05464030
Active, not recruiting
Phase 1
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
NCT05464030 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Colorectal Cancer
Investigational drug(s) / intervention(s)
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.
M9140: M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen.
Bevacizumab: Bevacizumab will be administered intravenously as per standard of care.
Capecitabine: Capecitabine will be administered orally as per standard of care.
5-fluorouracil (5-FU): 5-FU will be administered intravenously as per standard of care.
Folinic acid: Folinic acid will be administered intravenously as per standard of care.
Study 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
Eligibility
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
Primary outcome measure(s)
- Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) — up to 4 months
- Part 1: Recommended Dose Expansion (RDE) of M9140 — up to 4 months
- Parts 2B, 2C and 2D: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) — up to 8 months
- Part 2A: Number of Participants with Adverse Events (AEs) — up to 8 months
- Part 2A: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators — Time from first study treatment throughout the study duration until progressive disease or death up to approximately 8 months
- 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 from first study treatment to planned assessment at approximately 8 months
Trial sites (35)
| Facility | City | Region | Status |
|---|---|---|---|
| California Cancer Associates for Research & Excellence, Inc. | Encinitas | California | |
| California Cancer Associates for Research & Excellence, Inc. | Fresno | California | |
| Rhode Island Hospital | Providence | Rhode Island | |
| Mary Crowley Cancer Research | Dallas | Texas | |
| MD Anderson Cancer Center - Oncology | Houston | Texas | |
| NEXT Oncology | San Antonio | Texas | |
| The Ottawa Hospital Cancer Centre | Ottawa | Canada | |
| University Health Network - Princess Margaret Cancer Centre | Toronto | Canada | |
| National Cancer Center Hospital - Dept of Gastroenterology | Chūōku | Japan | |
| National Cancer Center Hospital East | Kashiwa-shi | Japan | |
| Saitama Cancer Center | Kitaadachi-gun | Japan | |
| Cancer Institute Hospital of JFCR | Kōtoku | Japan | |
| Aichi Cancer Center Hospital | Nagoya | Japan | |
| Kindai University Hospital | Osakasayama-shi | Japan | |
| Shizuoka Cancer Center | Sunto-gun | Japan | |
| Kanagawa Cancer Center | Yokohama | Japan | |
| Kyungpook National University Chilgok Hospital | Daegu | South Korea | |
| National Cancer Center | Goyang-si | South Korea | |
| Seoul National University Bundang Hospital | Seongnam | South Korea | |
| Asan Medical Center | Seoul | South Korea | |
| Samsung Medical Center | Seoul | South Korea | |
| Seoul National University Hospital | Seoul | South Korea | |
| Severance Hospital, Yonsei University Health System | Seoul | South Korea | |
| Hospital Clinic de Barcelona | Barcelona | Spain | |
| Hospital del Mar | Barcelona | Spain | |
| Hospital HM Nou Delfos | Barcelona | Spain | |
| Hospital Universitari Vall d'Hebron - VHIR | Barcelona | Spain | |
| Hospital Universitario Reina Sofia | Córdoba | Spain | |
| ICO l'Hospitalet - Hospital Duran i Reynals | L'Hospitalet de Llobregat | Spain | |
| Centro Integral Oncologico Clara Campal | Madrid | Spain | |
| Hospital Universitario 12 de Octubre | Madrid | Spain | |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | Spain | |
| Hospital Universitario Quironsalud Madrid - NEXT Oncology | Madrid | Spain | |
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | Spain | |
| Hospital Universitario Virgen del Rocio | Seville | Spain |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05464030 on ClinicalTrials.gov ↗ ← All trials in South Korea