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

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Solid Tumors, Gastric Cancer, Non-Small Cell Lung Cancer (NSCLC), Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma (PDAC)

In brief

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).

Key facts

Study ID

NCT06710132

Run by

EMD Serono Research & Development Institute, Inc.

People needed

184

Starts

2025-01-29

Expected to finish

2027-12-23

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Providence Medical Foundation — Santa Rosa, California, United States
• Georgetown University - Lombardi Comprehensive Cancer Center - 1134847 — Washington D.C., District of Columbia, United States
• D&H Cancer Research Center — Margate, Florida, United States
• Prisma Health Cancer Institute, ITOR, CRU — Greenville, South Carolina, United States
• Baptist Cancer Center — Memphis, Tennessee, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• NEXT Virginia — Fairfax, Virginia, United States
• 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, China
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China
• Sun Yat-sen University Cancer Center — Guangzhou, Guangzhou, China
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hebei, China
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
• Xiangya Hospital, Central South University — Changsha, Hu'nan, China
• Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology — Wuhan, Hubei, China
• Sichuan Cancer Hospital — Chengdu, Sichuan, China
• West China Hospital, Sichuan University — Chengdu, Sichuan, China
• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine - Department of Oncology Surgery — Hangzhou, Zhejiang, China
• University of California - Los Angeles - 300208353 — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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