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

Sponsor
IntoCell, Inc
Study ID
NCT07423117
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ITC-6146RO — DRUG
    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).

Study Details

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.

Key Dates

First listed
Feb 20, 2026
Start date
Feb 6, 2026
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
102 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1a/b
    The study consists of a Phase 1a dose-escalation part and a Phase 1b dose-expansion part.

Primary Outcome Measure

Phase 1a (Dose Escalation) Incidence of Adverse Events (AEs) [ Time Frame: Through study completion (Up to 2 years) ]

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