RecruitingPhase 1

Study to Assess the Effect of OCT-598 in Patients With Advanced Solid Tumors

South Korea51 participantsStarted 2025-12-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Part A: patients with advanced solid tumors and no effective standard therapy option or for whom standard-of-care treatment is not available or not appropriate as per the investigator's discretion
✓. Part B: patients with advanced solid tumors who are candidates for receiving docetaxel as a single agent for their cancer treatment, including but not limited to: advanced human epidermal growth factor receptor 2-negative breast cancer, recurrent/metastatic head and neck cancer, non-small cell lung cancer, prostate cancer, or gastric/gastroesophageal cancer

What they're measuring

To evaluate the safety and tolerability by measuring the frequency and severity of adverse events, as assessed by CTCAE v5.0

Timeframe: Approximately 2 years

Incidence of Dose-Limiting Toxicities (DLTs) for Determination of the Maximum Tolerated Dose (MTD)

Timeframe: Approximately 2 years

Incidence of adverse events and dose-limiting toxicities used to determine the recommended Phase 2 dose (RP2D) of OCT-598 (PART B only)

Timeframe: Approximately 1 years

Trial details

NCT IDNCT07358806

SponsorOscotec Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Sungsil Lee

82316287627 p1401@oscotec.com

View on ClinicalTrials.gov More Solid Tumor trials