Multinational phase 1 trial of precemtabart tocentecan for metastatic colorectal cancer

The cell surface protein CEACAM5 is overexpressed in colorectal cancer. Precemtabart tocentecan (Precem-TcT; previously M9140) is an anti-CEACAM5 antibody-drug conjugate with the topoisomerase 1 inhibitor exatecan as payload. The multinational phase 1 PROCEADE-CRC-01 trial evaluated Precem-TcT for heavily pretreated irinotecan-refractory metastatic colorectal cancer. The maximum tolerated dose was 2.8 mg/kg every three weeks. At dose levels 2.4 and 2.8 mg/kg 7.5% of patients had confirmed partial responses and 15% had unconfirmed partial responses; the median progression-free survival at these dose levels was 6.7 months (95% CI 4.6-8.8). The authors conclude that these early clinical data show safety and encouraging antitumor activity of Precem-TcT in patients with heavily pretreated mCRC.