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.

Study Overview

• Status: Not yet recruiting
• Conditions: Triple Negative Breast Cancer; Metastatic Solid Tumor; Non-small Cell Lung Cancer; Metastatic Castration-resistant Prostate Cancer
• Intervention / Treatment: Drug: ITC-6146RO

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1a/b; The study consists of a Phase 1a dose-escalation part and a Phase 1b dose-expansion part.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs)	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, (%)	Through study completion (Up to 2 years)
Phase 1b (Dose Expansion) Incidence of AEs	Grade 3 and 4 AEs, TEAEs, SAEs and AEs leading to discontinuation of study treatment, Evaluation of all-grade cardiac, renal, and pulmonary AEs, n, %	Through study completion (Up to 2 years)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a (Dose Escalation) Maximum Tolerated Dose (MTD) or Optimal Biological Dose (OBD) of ITC-6146RO	MTD/OBD will be reported as the final selected dose level for further investigation from Phase 1a dose escalation. MTD is determined by DLTs observed during the prespecified DLT observation period, and OBD is determined by meeting prespecified biological activity criteria (as defined in the protocol).	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) After Single-Dose Administration of ITC-6146RO	Plasma AUClast following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUCinf) After Single-Dose Administration of ITC-6146RO	Plasma AUCinf following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Maximum Observed Plasma Concentration (Cmax) After Single-Dose Administration of ITC-6146RO	Plasma Cmax following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Terminal Elimination Half-life (t1/2) After Single-Dose Administration of ITC-6146RO	Plasma terminal elimination half-life (t1/2) following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Time to Maximum Observed Plasma Concentration (Tmax) After Single-Dose Administration of ITC-6146RO	Plasma Tmax following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Clearance (CL) After Single-Dose Administration of ITC-6146RO	Plasma apparent clearance (CL) following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Volume of Distribution (Vz) After Single-Dose Administration of ITC-6146RO	Plasma apparent volume of distribution (Vz) following a single dose of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) After Multiple-Dose Administration of ITC-6146RO	Plasma AUClast following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Maximum Observed Plasma Concentration at Steady State (Cmax,ss) After Multiple-Dose Administration of ITC-6146RO	Plasma Cmax,ss (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Trough Plasma Concentration at Steady State (Ctrough,ss) After Multiple-Dose Administration of ITC-6146RO	Plasma Ctrough,ss (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Average Plasma Concentration Over the Dosing Interval at Steady State (Cav,τ) After Multiple-Dose Administration of ITC-6146RO	Plasma Cav,τ (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Terminal Elimination Half-life at Steady State (t1/2,ss) After Multiple-Dose Administration of ITC-6146RO	Plasma terminal elimination half-life at steady state (t1/2,ss) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) After Multiple-Dose Administration of ITC-6146RO	Plasma Tmax,ss (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Clearance at Steady State (CLss) After Multiple-Dose Administration of ITC-6146RO	Plasma apparent clearance at steady state (CLss) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Apparent Volume of Distribution at Steady State (Vss) After Multiple-Dose Administration of ITC-6146RO	Plasma apparent volume of distribution at steady state (Vss) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Accumulation Ratio After Multiple-Dose Administration of ITC-6146RO	Accumulation ratio (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Peak-to-Trough Fluctuation (PTF) After Multiple-Dose Administration of ITC-6146RO	Peak-to-trough fluctuation (PTF) (as applicable) following multiple-dose administration of ITC-6146RO will be calculated from plasma concentration-time data and summarized descriptively.	Through study completion (Up to 2 years)
Phase 1a (Dose Escalation) Incidence of Anti-Drug Antibodies (ADAs) to ITC-6146RO	Percentage of participants with detectable ADAs to ITC-6146RO (ADA-positive) based on a validated immunoassay.	Through study completion (Up to 2 years)
Phase 1b (Dose Expansion) Population Pharmacokinetic (PopPK) Parameters of ITC-6146RO	PopPK parameters (e.g.,clearance and volume of distribution) will be estimated using PopPK modeling based on measured ITC-6146RO concentrations.	Through study completion (Up to 2 years)
Phase 1b (Dose Expansion) Incidence of Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs) to ITC-6146RO	Percentage of participants with detectable ADAs, including NAbs, to ITC-6146RO, as determined by validated immunoassay and neutralization assays (as applicable).	Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Objective Response Rate (ORR) by Investigator per RECIST v1.1	ORR will be assessed by the investigator per RECIST v1.1	Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Duration of Response (DoR) by Investigator per RECIST v1.1	DoR will be assessed by the investigator per RECIST v1.1	Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Time to Response (TTR) by Investigator per RECIST v1.1	TTR will be assessed by the investigator per RECIST v1.1	Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Progression-Free Survival (PFS) by Investigator per RECIST v1.1	PFS will be assessed by the investigator per RECIST v1.1	Through study completion (Up to 2 years)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1b (Dose Expansion) Association Between ITC-6146RO Pharmacokinetic Parameters and Efficacy and Safety Endpoints	Correlation between ITC-6146RO pharmacokinetic (PK) parameters and selected efficacy, safety, and exploratory endpoints. Efficacy endpoints may include objective response rate (ORR) and progression-free survival (PFS). Associations will be evaluated using appropriate exposure-response analyses.	Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Overall Survival (OS)	OS is defined as the time from randomization until death from any cause.	Through study completion (Up to 2 years)
Phase 1a/b (Dose Escalation, Dose Expansion) Association Between B7-H3 Expression in Tumor Tissue and Anti-Tumor Efficacy	Correlation between B7-H3 expression in tumor tissue assessed by immunohistochemistry (IHC) and anti-tumor efficacy endpoints, including objective response rate (ORR) and progression-free survival (PFS). ORR is defined as the proportion of participants with confirmed complete or partial response, and PFS as time to disease progression or death per protocol-defined criteria. Associations will be evaluated using appropriate statistical methods. In participants with metastatic castration-resistant prostate cancer (mCRPC), PSA response rate (≥50% decline from baseline) and time to PSA progression will also be assessed.	Through study completion (Up to 2 years)

Collaborators and Investigators

• Sponsor: IntoCell, Inc

Study record dates

Study Major Dates

• Study Start (Estimated): February 6, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplastic Processes; Lung Neoplasms; Skin Diseases; Breast Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Breast Neoplasms; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Neoplasm Metastasis; Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms
• Other Study ID Numbers: ITC06P1-P01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No