NCT07423117Enrolling by invitationPhase 1
A Study of ITC-6146RO in Patients With Advanced or Metastatic Cancer Who Have Failed Standard Therapy
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- First submitted
- 4 Feb 2026
- Start date
- 24 Mar 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- IntoCell, Inc
- NCT number
- NCT07423117
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 102
- From 24 Mar 2026 to the primary completion date, 30 Jun 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- Inability to comply with study and follow-up procedures
- Pregnancy, lactation, or breastfeeding
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.