A Study of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy

The study consists of Phase 1a (dose escalation) and Phase 1b (dose expansion). In Phase 1a, sequential cohorts of subjects will receive escalating doses of ITC-6146RO to determine maximum tolerated dose (MTD) and/or optimal biological dose (OBD). In Phase 1b, the recommended phase 2 dose (RP2D) chosen from Phase 1a will be evaluated to further investigate safety, tolerability, pharmacokinetic (PK) and anti-tumor efficacy of ITC-6146RO.

NCT Number	NCT07423117
Lead Sponsor	IntoCell, Inc
Conditions	Metastatic Castration-resistant Prostate Cancer, Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Metastatic Solid Tumor
Enrollment	102 participants
Start Date	2026-02-06
Primary Completion	2027-06-30 (estimated)
Study Completion	2029-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-20