Arrivent Biopharma received FDA IND clearance for ARR-002 (AV-P138-ADC), an antibody-drug conjugate targeting MUC16 and NaPi2b. The IND clearance enables initiation of a Phase I trial expected to open in the second half of the year. The program’s initial focus is ovarian and endometrial cancers, with broader solid-tumor potential described in the company’s IND materials. For biotech teams tracking ADC development, the key milestone is the transition from preclinical readiness into first-in-human evaluation. IND clearances also shape competitive positioning in solid tumor ADC landscapes by signaling tolerability pathways, dose escalation plans, and biomarker strategy for target engagement.
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