CRB-701 (SYS6002) Nectin-4–targeted MMAE ADC shows early ~38% unconfirmed ORR in R/M cervical cancer

CRB-701 is a next-generation Nectin-4–targeting antibody–drug conjugate (ADC) delivering MMAE, evaluated in a Phase 1/2 dose-escalation/optimization study (NCT06265727) in recurrent/metastatic cervical cancer after ≥1 prior line (54 enrolled; 34 evaluable at this cut). In the randomized dose-optimization cohorts, unconfirmed ORR was 22.2% (4/18) at 2.7 mg/kg Q3W vs 37.5% (6/16) at 3.6 mg/kg Q3W; confirmed responses to date included 1/18 confirmed PR plus 1 confirmed CR at 2.7 mg/kg and 3/16 confirmed PRs at 3.6 mg/kg, with many patients awaiting confirmatory scans (no DOR/PFS yet; updated follow-up promised). Safety signals highlighted in the broader solid-tumor safety set (N=167) were keratitis plus common chemo-like AEs (anemia, alopecia, fatigue, dysgeusia), and the sponsor positions tolerability as favorable vs other MMAE ADCs; efficacy-wise, the interim confirmed activity looks in the ballpark of tisotumab vedotin’s historical ~24% confirmed ORR in previously treated R/M cervical cancer, though CRB-701’s current data are immature and heavily influenced by pending confirmations.