Phase 1 NEOK001 B7-H3×ROR1 bispecific ADC targets dual tumor antigens in solid tumors.
- Trial ID
- NCT07612176 on ClinicalTrials.gov
- Cancer type
- Multiple Solid Tumor
- Stage of research
- First-in-human
- Location
- 7 US locations (Nashville, Austin, Fairfax, San Antonio, New York, Dallas, Houston)
- Published in
- New in Oncology - June 11, 2026
This first-in-human, open-label Phase 1 study evaluates NEOK001 (also referenced as ABL206), a bispecific antibody-drug conjugate from NEOK Bio, Inc. designed to bind two tumor-associated surface targets—B7-H3 (CD276) and ROR1—to drive selective internalization and intracellular release of a cytotoxic payload (ADC mechanism: antibody-guided delivery of a linked chemotherapy “warhead” into cancer cells). The trial has Part A dose escalation with backfill to characterize safety, tolerability, pharmacokinetics, and define a recommended dose, followed by Part B dose expansion in selected solid-tumor populations with preliminary anti-tumor activity endpoints. Eligible participants have progressive, locally advanced unresectable or metastatic solid tumors; this is positioned for settings where patients have exhausted standard options and typically cycle through sequential systemic therapies (chemotherapy, targeted therapy when a driver is present, and immunotherapy/ADCs in certain histologies) or enroll in trials rather than having a single uniform standard regimen. The scientific/commercial angle is the dual-antigen (B7-H3 and ROR1) bispecific ADC design, aiming to improve tumor selectivity versus single-target ADCs in heterogeneous solid tumors.
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