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OncoMatch/Clinical Trials/NCT06710132

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

Is NCT06710132 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies M9140 for solid tumors.

Phase 1/2RecruitingEMD Serono Research & Development Institute, Inc.NCT06710132Data as of May 2026

Treatment: M9140The 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).

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Extracted eligibility criteria

Cancer type

Tumor Agnostic

Gastric Cancer

Non-Small Cell Lung Carcinoma

Pancreatic Cancer

Biomarker criteria

Required: CEACAM5 high expression (IHC ≥ 2+ in ≥ 50% of tumor cells) (IHC ≥ 2+ in ≥ 50% of tumor cells)

Participants in Part A with CEACAM5high GC/GEJC (defined as IHC ≥ 2+ staining in ≥ 50% of tumor cells)

Required: CEACAM5 low expression (IHC ≥ 2+ in < 50% of tumor cells) (IHC ≥ 2+ 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)

Required: CEACAM5 high expression (IHC ≥ 2+ in ≥ 50% of tumor cells) (IHC ≥ 2+ in ≥ 50% of tumor cells)

All participants will be screened using an IHC test to define CEACAM5 expression. Only participants with CEACAM5high expressing tumors will be eligible [PDAC]

Allowed: EGFR mutation

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

Disease stage

Required: Stage IV, STAGE III NOT ELIGIBLE FOR RESECTION OR CURATIVE RADIATION

Metastatic disease required

advanced or metastatic; Stage III not eligible for resection or curative radiation

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: systemic therapy (fluoropyrimidine, platinum agent) — advanced/metastatic

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

Must have received: immune checkpoint inhibitor — advanced/metastatic

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

Must have received: systemic therapy (FOLFIRINOX regimen, NALIRIFNOX regimen, Nab-paclitaxel/gemcitabine regimen) — advanced/metastatic

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

Cannot have received: topoisomerase inhibitor (irinotecan)

Participants with prior therapy with irinotecan

Lab requirements

Blood counts

adequate hematologic function as defined in protocol

Kidney function

adequate renal function as defined in protocol

Liver function

adequate hepatic function as defined in protocol

Participants with adequate hematologic, hepatic and renal function as defined in protocol

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • University of California - Los Angeles - 300208353 · Santa Monica, California
  • Providence Medical Foundation · Santa Rosa, California
  • Georgetown University - Lombardi Comprehensive Cancer Center - 1134847 · Washington D.C., District of Columbia
  • D&H Cancer Research Center · Margate, Florida
  • Memorial Cancer Institute at Memorial Healthcare System · Pembroke Pines, Florida

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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