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NCT07423117

PHASE1

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

Sponsor: IntoCell, Inc

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

102

Start Date

2026-02-06

Completion Date

2029-12-31

Last Updated

2026-02-20

Healthy Volunteers

Conditions

Metastatic Castration-resistant Prostate Cancer Non-small Cell Lung Cancer Triple Negative Breast Cancer Metastatic Solid Tumor

Interventions

DRUG

ITC-6146RO

ITC-6146RO will be administered as an intravenous (IV) infusion at protocol-specified dose levels and schedules in Phase 1a (dose escalation) and Phase 1b (dose expansion).

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