Investigational Drug
Precemtabart tocentecan
TrialFetch AI Analysis
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Overview
Precemtabart tocentecan (Precem-TcT; formerly M9140) is an investigational antibody–drug conjugate being studied in metastatic colorectal cancer and other advanced solid tumors. Human results are available from an early-phase colorectal cancer trial and a pancreatic cancer substudy, but these studies have not established whether it improves survival compared with existing treatments. (nature.com)
Mechanism of action
The antibody targets CEACAM5, a protein expressed on many colorectal tumors. It carries exatecan, a topoisomerase I inhibitor intended to damage cancer cells after delivery to the tumor. The conjugate has also shown bystander activity—effects on neighboring cells—in preclinical models. (nature.com)
Efficacy
- Metastatic colorectal cancer: In a phase 1 analysis of 41 previously irinotecan-treated patients given 2.8 mg/kg every three weeks, the reported objective response rate was 26.8% (11/41), although only five responses were confirmed at the May 2025 cutoff. Median progression-free survival was 6.9 months. (ascopubs.org)
- Metastatic pancreatic cancer: In a July 2026 interim report involving 46 patients whose tumors had high CEACAM5 expression, the confirmed response rate was 17.4% (8/46); it was 24.0% (6/25) among patients receiving second-line treatment. Median progression-free survival was 4.2 months overall. (annalsofoncology.org)
Safety
At the colorectal cancer dose above, grade 3 or higher treatment-emergent adverse events were chiefly blood-related, including neutropenia (48.8%) and anemia (43.9%). A treatment-related death from sepsis was reported; investigators also considered the death disease-related. In the pancreatic substudy, 78.3% had a grade 3 or higher treatment-emergent adverse event, and 13.0% permanently discontinued treatment because of adverse events. No treatment-related deaths or interstitial lung disease were reported in that substudy. These are small, early-phase datasets, so uncommon risks remain uncertain. (ascopubs.org)
Further reading
- Peer-reviewed phase 1 colorectal cancer study
- 2026 colorectal cancer dose-analysis abstract
- 2026 pancreatic cancer substudy abstract
Last updated: Sep 2026
Active trials using Precemtabart tocentecan
Found 3 active trials using this drug:
TrialFetch AI summary: Adults with metastatic colorectal cancer previously treated with irinotecan, oxaliplatin, a fluoropyrimidine, and bevacizumab, and with no more than two prior metastatic regimens, are randomized to precemtabart tocentecan alone, precemtabart tocentecan plus bevacizumab, or trifluridine/tipiracil plus bevacizumab. Precemtabart tocentecan is a CEACAM5-directed antibody–drug conjugate that delivers the topoisomerase I inhibitor exatecan.
ClinicalTrials.gov ID: NCT07549412
TrialFetch AI summary: Adults with previously treated locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma, NSCLC, or pancreatic ductal adenocarcinoma are enrolled in cohorts defined by CEACAM5 expression and, for NSCLC, EGFR status. All receive intravenous M9140 (precemtabart tocentecan), an investigational CEACAM5-targeting antibody–drug conjugate that delivers the topoisomerase I inhibitor exatecan.
ClinicalTrials.gov ID: NCT06710132
TrialFetch AI summary: This study enrolls patients with locally advanced or metastatic colorectal cancer that has progressed after, or is intolerant of, standard systemic therapy and who have ECOG performance status 0–1. Treatment is M9140 (precemtabart tocentecan), a CEACAM5-targeted antibody–drug conjugate delivering the topoisomerase I inhibitor exatecan, alone or with bevacizumab, with or without capecitabine or 5-fluorouracil/folinic acid.
ClinicalTrials.gov ID: NCT05464030
