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.
Treatment: M9140 — 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).
Check if I qualifyExtracted 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
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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