Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor)
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)
Sponsor: EMD Serono Research & Development Institute, Inc.
Listed as NCT06710132, this observational or N/A phase trial focuses on Gastric Cancer and Non-Small Cell Lung Cancer (NSCLC) and remains actively recruiting participants. Sponsored by EMD Serono Research & Development Institute, Inc., it has been updated 14 times since 2025, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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.
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.
Status Flow
Change History
14 versions recorded-
May 4, 2026 — Present [daily]
Recruiting
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Apr 28, 2026 — May 4, 2026 [daily]
Recruiting
Phase: PHASE1/PHASE2 → None
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Mar 2026 — Apr 2026 [monthly]
Recruiting PHASE1/PHASE2
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Feb 2026 — Mar 2026 [monthly]
Recruiting PHASE1/PHASE2
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Jan 2026 — Feb 2026 [monthly]
Recruiting PHASE1/PHASE2
▶ Show 9 earlier versions
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Dec 2025 — Jan 2026 [monthly]
Recruiting PHASE1/PHASE2
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Oct 2025 — Dec 2025 [monthly]
Recruiting PHASE1/PHASE2
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Sep 2025 — Oct 2025 [monthly]
Recruiting PHASE1/PHASE2
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Aug 2025 — Sep 2025 [monthly]
Recruiting PHASE1/PHASE2
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Jun 2025 — Aug 2025 [monthly]
Recruiting PHASE1/PHASE2
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May 2025 — Jun 2025 [monthly]
Recruiting PHASE1/PHASE2
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Apr 2025 — May 2025 [monthly]
Recruiting PHASE1/PHASE2
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Mar 2025 — Apr 2025 [monthly]
Recruiting PHASE1/PHASE2
Status: Not Yet Recruiting → Recruiting
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Dec 2024 — Mar 2025 [monthly]
Not Yet Recruiting PHASE1/PHASE2
First recorded
Eligibility 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).
Contact Information
- EMD Serono Research & Development Institute, Inc.
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Merck KGaA, Darmstadt, Germany
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Ancona, Italy , Badalona, Spain , Barcelona, Spain , Barcelona, Spain , Barcelona, Spain , Bedford Park, Australia , Beijing, China , Berlin, Germany , Bochum, Germany , Bordeaux, France and 71 more locations