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Investigating M9140 for advanced solid tumors

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)

Phase1; Phase2 Interventional EMD Serono · NCT06710132

This study is testing a new treatment called M9140 to see if it can help people with advanced solid tumors like gastric, lung, and pancreatic cancer feel better.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorEMD Serono Industry-sponsored
Drugs / interventionsradiation
Locations81 sites (Santa Monica, California and 80 other locations)
Trial IDNCT06710132 on ClinicalTrials.gov

What this trial studies

The PROCEADE PanTumor study evaluates the effectiveness of M9140, an anti-CEACAM5 antibody-drug conjugate, in treating various advanced solid tumors, including gastric cancer, non-small cell lung cancer, and pancreatic cancer. This multicenter, open-label study follows a master protocol with three substudies focusing on different tumor types. Participants will receive M9140 either as a standalone treatment or in combination with other therapies, with assessments of safety, tolerability, and pharmacokinetics throughout the study duration.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced or metastatic solid tumors expressing CEACAM5 who have previously undergone systemic therapies.

Not a fit: Patients with tumors that do not express CEACAM5 or those who are not eligible for the specified inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that express CEACAM5.

How similar studies have performed: Other studies utilizing antibody-drug conjugates have shown promising results, indicating potential for success in this novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Santa Monica, California and 80 other locations

+31 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Solid TumorsGastric CancerNon-Small Cell Lung CancerPancreatic CancerPancreatic Ductal AdenocarcinomaADCTOP1 inhibitorGastroesophageal junction cancer
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.