Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ITC-6146RO | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase 1a/b
- description
- The study consists of a Phase 1a dose-escalation part and a Phase 1b dose-expansion part.
- interventionNames
- Drug: ITC-6146RO
Primary outcomes (2)
- measure
- Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs)
- timeFrame
- Through study completion (Up to 2 years)
- description
- Grade 3 and 4 AEs, Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Dose-limiting toxicities (DLTs) and AEs leading to discontinuation of study treatment, Evaluation of all-grade cardiac, renal, and pulmonary AEs , n, (%)
- measure
- Phase 1b (Dose Expansion) Incidence of AEs
- timeFrame
- Through study completion (Up to 2 years)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available