Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)
Condition(s) studied
Investigational drug(s) / intervention(s)
M9140: All participants will receive 2.8 milligram per kilogram (mg/kg) M9140 intravenously (i.v.) every 3 weeks (q3w) on Day 1 of consecutive 21-day cycles.
Study summary
The PROCEADE PanTumor study aims to investigate M9140 in multiple tumor types which express carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5) and it is therefore designed as a matrix study. This study aims to assess the antitumor activity, tolerability, safety, and pharmacokinetics (PK) of M9140 as monotherapy or in combination treatments in adult participants with locally advanced/metastatic CEACAM5 expressing tumors. There will be 3 substudies under this Master Protocol that may be conducted in parallel.
* PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Gastric Cancer (Substudy GC);
* PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants with Advanced Non-Small Cell Lung Cancer (Substudy NSCLC);
* PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Pancreatic Cancer (Substudy PDAC).
Eligibility
Primary outcome measure(s)
- Substudies GC/NSCLC/PDAC: 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 to (planned) final assessment at approximately 48 months
Trial sites (81)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California - Los Angeles - 300208353 | Santa Monica | California | |
| Providence Medical Foundation | Santa Rosa | California | |
| Georgetown University - Lombardi Comprehensive Cancer Center - 1134847 | Washington D.C. | District of Columbia | |
| D&H Cancer Research Center | Margate | Florida | |
| Prisma Health Cancer Institute, ITOR, CRU | Greenville | South Carolina | |
| Baptist Cancer Center | Memphis | Tennessee | |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | |
| NEXT Virginia | Fairfax | Virginia | |
| Flinders Medical Centre | Bedford Park | Australia | |
| Nepean Cancer Care Centre | Kingswood | Australia | |
| Mater Misericordiae Ltd - PARENT | South Brisbane | Australia | |
| Macquarie University Hospital - PARENT | Sydney | Australia | |
| Ordensklinikum Linz Krankenhaus der Elisabethinen Linz - Pneumology | Linz | Austria | |
| LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie | Salzburg | Austria | |
| Medical University of Vienna - Department of Internal Medicine | Vienna | Austria | |
| Anhui Provincial Cancer Hospital | Hefei | Anhui | |
| Beijing Cancer Hospital | Beijing | Beijing Municipality | |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangzhou | |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hebei | |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | |
| Xiangya Hospital, Central South University | Changsha | Hu'nan | |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | Hubei | |
| Sichuan Cancer Hospital | Chengdu | Sichuan | |
| West China Hospital, Sichuan University | Chengdu | Sichuan | |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Department of Oncology Surgery | Hangzhou | Zhejiang | |
| Institut Bergonié - Service d'Oncologie Médicale | Bordeaux | France | |
| Centre Georges François Leclerc - Unité de Phase I | Dijon | France | |
| Centre Oscar Lambret - cancerologie generale | Lille | France | |
| Hopital Albert Calmette - CHU Lille - CHU Lille - Institut Coeur Poumon | Lille | France | |
| Hôpital Européen Georges Pompidou - Hématologie Oncologie | Paris | France | |
| Hôpital Saint-Antoine - Oncologie Médicale | Paris | France | |
| ICO - Site René Gauducheau - Service d'Oncologie medicale | Saint-Herblain | France | |
| Hôpital Foch - Service d'Oncologie Médicale | Suresnes | France | |
| Institut Claudius Regaud - Service d'oncologie médicale | Toulouse | France | |
| Institut Gustave Roussy - Pathologie Thoracique | Villejuif | France | |
| Krankenhaus Nordwest GmbH - Neurologische Klinik | Frankfurt am Main | Hesse | |
| St. Josef-Hospital im Katholischen Klinikum Bochum - Haematologie, Onkologie und Palliativmedizin | Bochum | North Rhine-Westphalia | |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz - I. Medizinische Klinik Gastroenterologie u Hepato. | Mainz | Rhineland-Palatinate | |
| Universitaetsklinikum Carl Gustav Carus TU Dresden - Medizinische Klinik I | Dresden | Saxony | |
| Universitaetsklinikum Leipzig AoeR - Universitaeres Krebszentrum Leipzig (UCCL) | Leipzig | Saxony |
+ 41 more sites — see the full list on the official registry below.
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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 NCT06710132 on ClinicalTrials.gov ↗ ← All trials in the USA