Trials / Recruiting
RecruitingNCT07358806
Study to Assess the Effect of OCT-598 in Patients With Advanced Solid Tumors
A Phase 1 Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of OCT-598 as a Single Agent and in Combination With Standard-of-Care Treatment in Patients With Advanced Solid Tumors
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 51 (estimated)
- Sponsor
- Oscotec Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 1 study intended to determine the MTD of OCT-598 following multiple-dose therapy and to establish the RP2D for OCT-598 as a single agent, by assessing its safety and tolerability as monotherapy and in combination with standard-of-care treatments in patients with advanced solid tumors.
Conditions
- Solid Tumor
- Breast Cancer
- Head and Neck Cancer
- Non-Small Cell Lung Cancer
- Prostate Cancer
- Gastric/Gastroesophageal Junction Cancer
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OCT-598 | OCT-598 will be administered orally once daily. |
| COMBINATION_PRODUCT | Docetaxel | Docetaxel will be provided for Part B only to support the combination therapy with the standard-of-care regimen. |
Timeline
- Start date
- 2025-12-18
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2026-01-22
- Last updated
- 2026-01-22
Locations
3 sites across 1 country: South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07358806. Inclusion in this directory is not an endorsement.