Varsetatug masetecan (EpCAM PROBODY Topo-1 ADC, CX-2051) - (Varseta-M)

Aug. 27, 2026: CytomX Therapeutics (NASDAQ: CTMX) said the FDA granted Fast Track Designation to Varseta-M (varsetatug masetecan; CX-2051) for relapsed/refractory metastatic colorectal cancer.

Varseta-M is a masked, conditionally activated EpCAM-targeting antibody-drug conjugate with a topoisomerase-1 inhibitor payload. The company said the designation follows previously reported encouraging Phase 1 data. CytomX stated it is working toward initiating a potential Varseta-M monotherapy registrational study in relapsed/refractory metastatic colorectal cancer in 1H 2027.

The release also notes ongoing and planned clinical trials of Varseta-M alone and in combination with other drugs, but provides no new efficacy or safety data in this announcement.