Suzhou, China-based Phrontline Biopharma dosed the first patient in a Phase I/II first-in-human study of TJ102, an investigational FRα × CDH6 bispecific dual-payload antibody–drug conjugate (ADC), in patients with advanced or metastatic ovarian cancer and other solid tumors.
TJ102 targets two antigens — folate receptor alpha (FRα/FOLR1) and CDH6 — and co-delivers a topoisomerase I inhibitor and a microtubule inhibitor through a single branched, protease-cleavable DLP1 linker, a design intended to address antigen heterogeneity and resistance that can limit single-target, single-payload ADCs. AbbVie's Elahere (mirvetuximab soravtansine), a single-target FRα ADC, holds full US FDA approval and EU marketing authorization for FRα-positive, platinum-resistant ovarian cancer, establishing FRα as a validated target but leaving the bispecific dual-payload approach untested clinically.
The open-label, multicenter Phase I/II study (NCT07778498) is being conducted under a US FDA-cleared investigational new drug application and a China NMPA-approved clinical trial application. It will assess safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity across dose-escalation and expansion cohorts. No efficacy data are available at this stage.
In the CDH6-targeted ADC space, Daiichi Sankyo and Merck & Co. reported a 50.5% confirmed overall response rate across 107 patients in the Phase II portion of their study of raludotatug deruxtecan in platinum-resistant recurrent ovarian cancer, and have advanced to a Phase III comparison against investigator's choice chemotherapy. Other companies with CDH6-directed ADCs in development include OnCusp Therapeutics and NextCure.