PROCEADE PanTumor: A Phase 1b/2, Multicenter, Open-Label Study of Anti-CEACAM5 Antibody-Drug Conjugate M9140 in Participants With Advanced Solid Tumors (Master Protocol)

Status: Recruiting
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California - Los Angeles - 300208353
RECRUITING
Santa Monica
Providence Medical Foundation
RECRUITING
Santa Rosa
South Carolina
Prisma Health Cancer Institute, ITOR, CRU
RECRUITING
Greenville
Tennessee
Baptist Memorial Health Care -Memphis
RECRUITING
Memphis
Texas
University of Texas M. D. Anderson Cancer Center - Partner
RECRUITING
Houston
Virginia
NEXT Virginia
RECRUITING
Fairfax
Other Locations
Australia
Flinders Medical Centre
RECRUITING
Bedford Park
Nepean Cancer Care Centre
RECRUITING
Kingswood
Mater Misericordiae Ltd - PARENT
RECRUITING
South Brisbane
Macquarie University Hospital - PARENT
RECRUITING
Sydney
Austria
Ordensklinikum Linz Krankenhaus der Elisabethinen Linz - Pneumology
RECRUITING
Linz
LKH - Universitätsklinikum der PMU Salzburg - Innere Med III/Hämatologie und Onkologie
RECRUITING
Salzburg
France
Institut Bergonié - Service d'Oncologie Médicale
RECRUITING
Bordeaux
Centre Georges François Leclerc - Unité de Phase I
RECRUITING
Dijon
Centre Oscar Lambret - cancerologie generale
RECRUITING
Lille
Hopital Albert Calmette - CHU Lille - CHU Lille - Institut Coeur Poumon
RECRUITING
Lille
Hôpital Européen Georges Pompidou - Hématologie Oncologie
RECRUITING
Paris
Hôpital Saint-Antoine - Oncologie Médicale
RECRUITING
Paris
ICO - Site René Gauducheau - Service d'Oncologie medicale
RECRUITING
Saint-herblain
Hôpital Foch - Service d'Oncologie Médicale
RECRUITING
Suresnes
Hopital Rangueil - Service d'Oncologie médicale
RECRUITING
Toulouse
Japan
National Cancer Center Hospital
RECRUITING
Chūōku
Nara Medical University Hospital - Dept of Oncology
RECRUITING
Kashihara-shi
Cancer Institute Hospital of JFCR
RECRUITING
Kōtoku
Saiseikai Kumamoto Hospital - 300175708
RECRUITING
Kumamoto
Kurume University Hospital
RECRUITING
Kurume-shi
Niigata Cancer Center Hospital - 300176282
RECRUITING
Niigata
Kindai University Hospital
RECRUITING
Osakasayama-shi
NHO Hokkaido Cancer Center - 300175802
RECRUITING
Sapporo
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
Chonnam National University Hwasun Hospital
RECRUITING
Hwasun-gun
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Asan Medical Center
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System - Division of Infectious Diseases
RECRUITING
Seoul
Contact Information
Primary
Communication Center
service@emdgroup.com
+496151725200
Time Frame
Start Date: 2025-01-29
Estimated Completion Date: 2028-01-26
Participants
Target number of participants: 250
Treatments
Experimental: Substudy GC: M9140 Monotherapy - Part A CEACAM5 High
Experimental: Substudy GC: M9140 Monotherapy - Part B CEACAM5 Low
Experimental: Substudy NSCLC: M9140 Monotherapy - Part A CEACAM5 High EGFR Wt
Experimental: Substudy NSCLC: M9140 Monotherapy - Part B CEACAM5 High EGFR mut
Experimental: Substudy PDAC: M9140 Monotherapy - Part A CEACAM5 High
Sponsors
Collaborators: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany, Merck KGaA, Darmstadt, Germany
Leads: EMD Serono Research & Development Institute, Inc.

This content was sourced from clinicaltrials.gov

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