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Study to Assess the Effect of OCT-598 in Patients With Advanced Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT07358806•Oscotec Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Female or male, ≥18 years of age (or ≥19 years according to according to the local regulatory guidance), at the time of screening
•Signed informed consent prior to any study-related procedures that are not considered standard of care
•Life expectancy \>12 weeks in the opinion of the investigator
•Adequate organ and marrow function, defined as follows:
•* Absolute neutrophil count ≥1.5 × 109/L
•* Platelets ≥100,000/μL
•* Hemoglobin ≥9.0 g/dL
•* Total bilirubin \<1.5 × ULN
•* ALT or AST ≤2.5 × ULN
•* Creatinine clearance calculated using the Cockcroft-Gault formula ≥60 mL/min (In equivocal cases, a 24-hour urine collection test can be used to estimate the creatinine clearance more accurately)
+11 more criteria

Exclusion Criteria

•Treatment with any IP or other anticancer therapy (including chemotherapy, antibody-drug conjugates, targeted agents, and immunotherapy) within 28 days or 5 half-lives, whichever is longer, of the first dose of study drug.
•Prior clinically significant treatment-related toxicities not resolved to Grade ≤1 or baseline (per CTCAE version 5.0) except for alopecia. Participants with stable Grade 2 peripheral neuropathy or endocrinopathies with stable endocrine replacement therapy are eligible. Patients with irreversible toxicity that is not reasonably expected to be exacerbated by study treatment (eg, vitiligo or hearing loss) may be eligible after discussion with the Sponsor.
•Prior treatment with an EP2 and/or EP4 antagonist.
•Major surgery or wide-field radiation within 28 days or limited field palliative radiation within 7 days prior to the first dose of the study drug.

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

Key Dates

Start Date

December 18, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

January 22, 2026

Enrollment

ESTIMATED participants

Conditions

Solid TumorBreast CancerHead and Neck CancerNon-Small Cell Lung CancerProstate CancerGastric/Gastroesophageal Junction Cancer

Interventions

OCT-598

DRUG

Docetaxel

COMBINATION_PRODUCT

Contacts

Sungsil Lee

CONTACT

82316287627 p1401@oscotec.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

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