RecruitingPhase 1NCT07358806

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


Sponsor

Oscotec Inc.

Enrollment

51 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new experimental drug called OCT-598 in people with advanced solid tumors (cancers that have spread and no longer respond to standard treatments). It is an early-phase trial focused on safety, dosing, and early signs of effectiveness. **You may be eligible if...** - You are 18 or older (19 or older in some locations) - You have advanced cancer with at least one measurable tumor - You have no good remaining standard treatment options (Part A), OR you are a candidate for docetaxel chemotherapy for cancers such as breast cancer, head and neck cancer, lung cancer, prostate cancer, or gastric cancer (Part B) - Your liver, kidneys, blood, and heart function are within acceptable levels - Your expected survival is more than 12 weeks **You may NOT be eligible if...** - You have had chemotherapy, immunotherapy, or other anti-cancer treatment in the past 28 days (or 5 half-lives of the drug) - You have uncontrolled brain metastases - You have serious heart problems - You are pregnant or breastfeeding - You have active autoimmune disease requiring systemic treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOCT-598

OCT-598 will be administered orally once daily.

COMBINATION_PRODUCTDocetaxel

Docetaxel will be provided for Part B only to support the combination therapy with the standard-of-care regimen.


Locations(3)

National Cancer Center

Goyang-si, South Korea

Seoul National University Bundang Hospital (SNUBH)

Seongnam-si, South Korea

Asan Medical Center

Seoul, South Korea

View Full Details on ClinicalTrials.gov

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NCT07358806


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