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Not yet recruiting NCT07423117

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ITC-6146RO.
Who it may be relevant to
Registry conditions: Metastatic Castration-resistant Prostate Cancer, Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Metastatic Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

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).

Primary outcome measures

  • Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs) [Time frame: Through study completion (Up to 2 years)]
  • Phase 1b (Dose Expansion) Incidence of AEs [Time frame: Through study completion (Up to 2 years)]
Secondary outcome measures (12)
  • Phase 1a (Dose Escalation) Maximum Tolerated Dose (MTD) or Optimal Biological Dose (OBD) of ITC-6146RO [Time frame: 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 [Time frame: 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 [Time frame: Through study completion (Up to 2 years)]
  • Phase 1a (Dose Escalation) Maximum Observed Plasma Concentration (Cmax) After Single-Dose Administration of ITC-6146RO [Time frame: Through study completion (Up to 2 years)]
  • Phase 1a (Dose Escalation) Terminal Elimination Half-life (t1/2) After Single-Dose Administration of ITC-6146RO [Time frame: 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 [Time frame: Through study completion (Up to 2 years)]
  • Phase 1a (Dose Escalation) Apparent Clearance (CL) After Single-Dose Administration of ITC-6146RO [Time frame: Through study completion (Up to 2 years)]
  • Phase 1a (Dose Escalation) Apparent Volume of Distribution (Vz) After Single-Dose Administration of ITC-6146RO [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Through study completion (Up to 2 years)]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07423117 · ITC06P1-P01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗