Trials / Not Yet Recruiting
Not Yet RecruitingNCT07423117
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
- Status
- Not Yet Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- Sponsor
- IntoCell, Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Metastatic Castration-resistant Prostate Cancer
- Non-small Cell Lung Cancer
- Triple Negative Breast Cancer
- Metastatic Solid Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2026-02-06
- Primary completion
- 2027-06-30
- Completion
- 2029-12-31
- First posted
- 2026-02-20
- Last updated
- 2026-02-20
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07423117. Inclusion in this directory is not an endorsement.