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

Last updated: May 5, 2025
Sponsor: EMD Serono Research & Development Institute, Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Pancreatic Cancer

Stomach Cancer

Pancreatitis

Treatment

M9140

Clinical Study ID

NCT06710132
MS202329_0010
2024-517817-34-00
2024-517818-15-00
2024-517819-74-00
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 inprotocol

  • 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 ofadvanced or metastatic, HER2 negative, gastric or GEJ (with an epicenter 2centimeter (cm) proximal or distal to the GEJ) adenocarcinoma, who wereintolerant/refractory to or progressed after systemic therapies for theadvanced/metastatic stage that must have included (provided there is no medicalcontraindication and these agents are locally approved and available) afluoropyrimidine and a platinum agent and an Immune checkpoint inhibitors (ICI) forparticipants with a known microsatellite instability-high (MSI-H) status orparticipants 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 inless 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 documentedadvanced (Stage III not eligible for resection or curative radiation) or metastaticNSCLC with or without driver genomic alterations

  • Participants must have been intolerant/refractory to or progressed after systemictherapies 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 occurredduring or within 3 months after regimen completion, are considered to have receiveda line of treatment in the advanced setting

  • Participants in Part A with CEACAM5 high-expressing EGFR tumors (includingparticipants with any driver genomic alterations other than EGFR mutations

  • Participants in Part B with CEACAM5 high known EGFR mutated tumors as assessedaccording to local clinical practice

  • Other protocol defined inclusion criteria could apply

Substudy PDAC:

  • Participants with histologically or cytologically confirmed advanced or metastaticPDAC, who were intolerant/refractory to or progressed after systemic therapies forthe advanced metastatic stage that must have included (provided there is no medicalcontraindications, and these agents are locally approved and available; FOLFIRINOXregimen or NALIRIFNOX regimen or Nab-paclitaxel/gemcitabine regimen

  • Participants must have received and progressed (according to RECIST 1.1) on at leastone 1 line of therapy for the treatment of advanced/metastatic disease but no morethan 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

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 situof the cervix, benign prostate neoplasm/hypertropia, or malignancy that in theopinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, isconsidered cured with minimal risk of recurrence within 3 years)

  • Participants with known brain metastases, except those meeting the followingcriteria: Brain metastases that have been treated locally and are clinically stablefor at least 4 weeks prior to the start of treatment; No ongoing neurologicalsymptoms that are related to the brain localization of the disease (sequelae thatare 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., ulcerativecolitis, 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 procedurewithin 180 days of study entry. Calculated QTc average (using the Fridericiacorrection 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

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: M9140
Phase: 1/2
Study Start date:
January 29, 2025
Estimated Completion Date:
January 31, 2029

Study Description

The study follows a master protocol concept with several separate substudies in specific indications.

  • Substudy GC: The study duration per participant is on an average approximately 10 months. This includes a 28-day Screening period, infusion (approximately 1 hour) on Day 1 of every cycle, and Safety Follow-up Visit 30 (± 3) days after the last dose of M9140.

  • Substudy NSCLC: Study duration per participant is approximately 12 months. This includes a 28-day Screening period, infusion (approximately 1 hour) on Day 1 of every cycle, and Safety Follow-up Visit 30 (± 3) days after the last dose of M9140.

  • Substudy PDAC: Study duration per participant is on an average approximately 8 months. This includes a 28-day Screening period, infusion (approximately 1 hour) on Day 1 of every cycle, and Safety Follow-up Visit 30 (±3) days after the last dose of M9140.

Connect with a study center

  • Research Site

    Darmstadt,
    Germany

    Site Not Available

  • Saiseikai Kumamoto Hospital - 300175708

    Kumamoto-shi,
    Japan

    Active - Recruiting

  • Kyungpook National University Chilgok Hospital

    Daegu,
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Active - Recruiting

  • Research Site

    Billerica, Massachusetts 01821
    United States

    Site Not Available

  • NEXT Virginia

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

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