Testing ITC-6146RO in advanced cancers that no longer respond to standard treatment
Tests ITC-6146RO for safety in adults with advanced cancer after standard therapy failed.
Plain-language title generated from the registry record
Registry title: A Study of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy
Key facts
- Where
- Seoul, South KoreaSee the 3 sites
- Phase
- Phase 1
Where in South Korea
- Asan Medical CenterSeoul, South KoreaTaking people
- Samsung Medical CenterSeoul, South KoreaTaking people
- Severance hospitalSeoul, South KoreaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IntoCell, Inc
- Trial code
- NCT07423117
- Record updated
- 10 November 2026
- Original description
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).Read full original descriptionShow less
A Phase 1a/b, Open-label, Multicenter, First-in-human, Dose Escalation/Expansion Study With Multiple Cohorts to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Efficacy 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.
Inclusion: Adult males and females aged ≥ 19 years (Korea) or ≥ 18 years (United States); Patients must be individuals who have voluntarily agreed to participate in the study after receiving a detailed explanation and fully understanding the nature of the clinical trial, and who have provided written informed consent; Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease; Patients must have at least one evaluable or measurable lesion based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1). However, for patients with prostate cancer, eligibility will be determined based on Prostate Cancer Working Group 3 (PCWG3); Patients who have received standard therapies and have no remaining clinically available approved treatment options; Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; Estimated life expectancy of ≥ 3 months.
Exclusion: Patients with a prior history of anticancer therapy before the first dose; Patients who are currently participating in a clinical trial or have participated in a clinical trial involving a medical device or investigational product within 28 days prior to the first administration of ITC-6146RO; Has prior treatment with duocarmycin-containing agents; Prior allogenic bone marrow transplantation or solid organ transplantation; History of autoimmune disease, treatment with systemic immunosuppressive medications; History of another active malignancy within the past 3 years; Patients with central nervous system metastases, leptomeningeal disease, or spinal cord compression; Known Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV) infection with active disease exception of the following conditions; Tuberculosis with active disease; Active infection necessitating systemic therapy; Patients with clinically significant pulmonary disease; Inability to comply with study and follow-up procedures; Pregnancy, lactation, or breastfeeding.