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Clinical Trials in the USA / NCT06710132
Active, not recruiting Phase 1/2

Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)

NCT06710132 · tracked via the Priya Life Science USA tracker
Sponsor
EMD Serono Research & Development Institute, Inc.
Phase
Phase 1/2
Started
2025-01-29
Last updated
2026-07-30

Condition(s) studied

Solid TumorsGastric CancerNon-Small Cell Lung Cancer (NSCLC)Pancreatic CancerPancreatic Ductal Adenocarcinoma (PDAC)

Investigational drug(s) / intervention(s)

M9140

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Participants are capable of signing informed consent as defined in protocol * 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 * Participant must have at least 1 lesion that is measurable using RECIST v1.1. * Other protocol defined inclusion criteria could apply Substudy GC: * Participants in Part A and Part B with documented histopathological diagnosis of advanced or metastatic, HER2 negative, gastric or GEJ (with an epicenter 2 centimeter (cm) proximal or distal to the GEJ) adenocarcinoma, who were intolerant/refractory to or progressed after systemic therapies for the advanced/metastatic stage that must have included (provided there is no medical contraindication and these agents are locally approved and available) a fluoropyrimidine and a platinum agent and an Immune checkpoint inhibitors (ICI) for participants with a known microsatellite instability-high (MSI-H) status or participants whose tumor express PD-L1 with a CPS greater than or equal (\>=) 1 * Participants must have received and progressed (according to RECIST 1.1) on at least 1 line of therapy for the treatment of advanced/metastatic disease but no more than 2 * Participants in Part A with CEACAM5high GC/GEJC (defined as IHC \>= 2+ staining in \>= 50% of tumor cells) * Participants in Part B with CEACAM5low GC/GEJC (defined as IHC \>= 2+ staining in less than (\<) 50% of tumor cells) * Other protocol defined inclusion criteria could apply Substudy NSCLC: * Participants in Part A and Part B with histologically or cytologically documented advanced (Stage III not eligible for resection or curative radiation) or metastatic NSCLC with or without driver genomic alterations * Participants must have been intolerant/refractory to or progressed after systemic therapies for the advanced/metastatic stage * Participants must have received and progressed (according to RECIST 1.1) on at least 1 line of therapy for the treatment of advanced/metastatic disease but no more than 3 * Participants who received a platinum-containing regimen or a targeted therapy as (neo)-adjuvant therapy for early-stage disease, if relapse or metastases occurred during or within 3 months after regimen completion, are considered to have received a line of treatment in the advanced setting * Participants in Part A with CEACAM5 high-expressing EGFR tumors (including participants with any driver genomic alterations other than EGFR mutations * Participants in Part B with CEACAM5 high known EGFR mutated tumors as assessed according to local clinical practice * Other protocol defined inclusion criteria could apply Substudy PDAC: * Participants with histologically or cytologically confirmed advanced or metastatic PDAC, who were intolerant/refractory to or progressed after systemic therapies for the advanced metastatic stage that must have included (provided there is no medical contraindications, and these agents are locally approved and available; FOLFIRINOX regimen or NALIRIFNOX regimen or Nab-paclitaxel/gemcitabine regimen * Participants must have received and progressed (according to RECIST 1.1) on at least one 1 line of therapy for the treatment of advanced/metastatic disease but no more than 2 * All participants will be screened using an IHC test to define CEACAM5 expression. Only participants with CEACAM5high expressing tumors will be eligible * 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 * Cardiac arrhythmia, 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 Substudy GC - Participants with prior therapy with irinotecan Substudy NSCLC: \- Participants with prior therapy with irinotecan Substudy PDAC: none

Primary outcome measure(s)

Trial sites (81)

FacilityCityRegionStatus
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.

More EMD Serono Research & Development Institute, Inc. trials in the USA

Other trials for the same condition

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 NCT06710132 on ClinicalTrials.gov ↗ ← All trials in the USA