RecruitingPhase 1interventionalRules rewrite

Phase 1: testing ITC-6146RO for Metastatic Castration-resistant Prostate Cancer

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).

Official registry: https://clinicaltrials.gov/study/NCT07423117 · IntoCell, Inc · enrollment listed as 102

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ITC-6146RO. The registry lists allocation as na. The study consists of Phase 1a (dose escalation) and Phase 1b (dose expansion).

They plan to enroll about 102 people at 3 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: ITC-6146RO

Primary outcome (registry wording): Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs)

Who it is for (from inclusion criteria)

Ages 18 Years to any
Adult males and females aged ≥ 19 years (Korea) or ≥ 18 years (United States)
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

Who the registry excludes

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

Public study contact (from the registry)

EUNJU JEON, PhD

010-7557-3589

ejjeon@intocell.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

3 listed

Severance Hospital — Seoul, Seoul, South Korea (recruiting)
Asan Medical Center — Seoul, Seoul, South Korea (recruiting)
Samsung Medical Center — Seoul, Seoul, South Korea (recruiting)

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FAQ about this NCT record

Is NCT07423117 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07423117?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07423117?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary