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Een onderzoek naar ITC-6146RO bij patiënten met gevorderde of uitgezaaide kanker die niet hebben gereageerd op standaardtherapie

5 november 2026 bijgewerkt door: IntoCell, Inc

Een fase 1a/b, open-label, multicentrisch, first-in-human, dosis-escalatie/expansie studie met meerdere cohorten om de veiligheid, verdraagbaarheid, farmacokinetiek en preliminaire antitumorale werkzaamheid van ITC-6146RO te evalueren bij patiënten met gevorderde of gemetastaseerde kanker die standaardtherapie hebben ondergaan zonder succes

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

102

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

  • Naam: SOOJIN OH, MS
  • Telefoonnummer: 042-716-0339 010-7664-7484
  • E-mail: sjoh@intocell.com

Studie Locaties

  • Zuid -Korea
    • Seoul
      • Seoul, Seoul, Zuid -Korea, 06351
        • Werving
        • Samsung Medical Center
        • Contact:
      • Seoul, Seoul, Zuid -Korea, 05505
        • Werving
        • Asan Medical Center
        • Contact:
      • Seoul, Seoul, Zuid -Korea, 03722
        • Werving
        • Severance Hospital
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Phase 1a/b

The study consists of a Phase 1a dose-escalation part and a Phase 1b dose-expansion part.
Geneesmiddel: 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).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs)
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 1a (Dose Escalation) Maximum Tolerated Dose (MTD) or Optimal Biological Dose (OBD) of ITC-6146RO
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

PFS will be assessed by the investigator per RECIST v1.1
Through study completion (Up to 2 years)

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phase 1b (Dose Expansion) Association Between ITC-6146RO Pharmacokinetic Parameters and Efficacy and Safety Endpoints
Tijdsspanne: Through study completion (Up to 2 years)

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)
Tijdsspanne: Through study completion (Up to 2 years)

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
Tijdsspanne: Through study completion (Up to 2 years)

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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

IntoCell, Inc

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

24 maart 2026

Primaire voltooiing (Geschat)

30 juni 2027

Studie voltooiing (Geschat)

31 december 2029

Studieregistratiedata

Eerst ingediend

4 februari 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 februari 2026

Eerst geplaatst (Werkelijk)

20 februari 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2026

Laatste update ingediend die voldeed aan QC-criteria

5 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ITC06P1-P01

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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