ITC-6146RO in advanced cancers beyond standard therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 trial with two parts: dose-escalation to find the maximum tolerated or optimal dose, and a dose-expansion to further study safety, how the body handles the drug, and preliminary anti-tumor activity. It includes patients with metastatic castration-resistant prostate cancer, non-small cell lung cancer, triple-negative breast cancer, and other metastatic solid tumors. Doses from Phase 1a will determine RP2D for Phase 1b, where safety, PK, and early efficacy data will be collected. Eligible participants must have measurable disease, adequate organ function, and have exhausted standard therapies. The study is conducted at three Seoul-based centers and is sponsored by IntoCell, Inc.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adult males and females aged ≥ 19 years (Korea) or ≥ 18 years (United States)
2. 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.
3. Pathological confirmation of malignancy and evidence of metastatic or surgically unresectable disease
4. 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)
5. Patients who have received standard therapies and have no remaining clinically available approved treatment options.
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
7. Estimated life expectancy of ≥ 3 months

Exclusion Criteria:

1. Inability to comply with study and follow-up procedures
2. Patients with a prior history of anticancer therapy before the first dose
3. History of another active malignancy within the past 3 years
4. Patients with central nervous system metastases, leptomeningeal disease, or spinal cord compression.
5. 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
6. Has prior treatment with duocarmycin-containing agents
7. Pregnancy, lactation, or breastfeeding
8. Known Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) and Hepatitis B virus (HBV) infection with active disease exception of the following conditions.
9. Tuberculosis with active disease
10. Active infection necessitating systemic therapy
11. Prior allogenic bone marrow transplantation or solid organ transplantation
12. History of autoimmune disease, treatment with systemic immunosuppressive medications
13. Patients with clinically significant pulmonary disease

Where it's running

• Severance Hospital
  Seoul, Seoul, South Korea Recruiting
• Asan Medical Center
  Seoul, Seoul, South Korea Recruiting
• Samsung Medical Center
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: EUNJU JEON, PhD
• Email: ejjeon@intocell.com
• Phone: 010-7557-3589

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.