drugset / Trial / NCT07423117

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

NCT07423117 ↗

Phase 1 Not yet recruiting 102 enrolled IntoCell, Inc
NaSequentialOpen-labelTreatment

Summary

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.

Timeline

Start
2026-02-06
Primary completion
2027-06-30
Completion
2029-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject ITC-6146RO Unknown — Intravenous