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

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 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