IntoCell receives FDA IND approval for advanced solid tumor treatment ‘ITC-6146RO’

CAR-T Digest - August 2020

27 November 2025: IntoCell receives FDA IND approval for advanced solid tumor treatment ‘ITC-6146RO’

IntoCell received FDA IND approval for ITC-6146RO, a B7-H3 targeting antibody-drug conjugate for advanced solid tumors, including mCRPC, NSCLC, and TNBC all areas with high unmet need and no approved B7-H3 ADCs
ITC-6146RO uses IntoCell’s proprietary next-generation OHPAS linker and PMT payload modification technologies, combined with a duocarmycin-class payload, distinguishing it from typical camptothecin-based ADCs
The Phase 1 clinical trial will enroll up to 102 patients who have failed standard therapies, assessing safety, tolerability, pharmacokinetics, and early anti-tumor activity
Phase 1a will focus on dose escalation, while Phase 1b will evaluate dose expansion and preliminary efficacy across mCRPC, NSCLC, and TNBC to determine the recommended Phase 2 dose
IntoCell said the IND approval validates its platform technologies and plans to accelerate global business development, technology transfer, and partnership opportunities