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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

Study to Assess the Effect of OCT-598 in Patients With Advanced Solid Tumors (NCT07358806) is a Phase 1 interventional studying Solid Tumor and Breast Cancer, sponsored by Oscotec Inc.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Solid Tumor, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 51 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Solid Tumor subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Female or male, ≥18 years of age (or ≥19 years according to according to the local regulatory guidance), at the time of screening - Signed willing to sign a consent form 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 - platelet count at least 100,000/μL - blood count (hemoglobin) at least 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) - LVEF \>50% or within institutional values - At least 1 measurable lesion based on RECIST version 1.1 - Cohort-specific disease requirements: 1. 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 2. 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 - Docetaxel-appropriate (Part B): patients who have not received prior docetaxel in the advanced setting are eligible Who Should NOT Join This Trial: - 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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) * LVEF \>50% or within institutional values * At least 1 measurable lesion based on RECIST version 1.1 * Cohort-specific disease requirements: 1. 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 2. 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 * Docetaxel-appropriate (Part B): patients who have not received prior docetaxel in the advanced setting are eligible 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. * Known active central nervous system metastasis. Patients with asymptomatic previously treated brain metastasis are eligible if they are clinically stable for at least 4 weeks prior to enrollment and do not require treatment with corticosteroids. * Treatment with systemic corticosteroids at a dose of \>10 mg of prednisone or equivalent at the time of enrollment, or any other immunosuppressive medication 7 days before the first dose of the study drug. Premedication with corticosteroids prior to chemotherapy administration in the combination phase is allowed, as per the site standard of care. Systemic treatment with NSAIDs, COX2 inhibitors, or synthetic prostaglandins within 5 half-lives prior to the first dose of study drug (acetylsalicylic acid ≤160 mg/day, or 325 mg ≤3 times/week is permitted). * Patients who are pregnant, breastfeeding, or planning to become pregnant during the study . * Concomitant active malignancy or previous malignancy within 2 years of the time of enrollment. Patients with adequately resected basal or squamous cell carcinoma of the skin, carcinoma in situ or the cervix or breast, stage 1 prostate cancer, or other malignancy deemed to be cured by prior therapy in the judgment of the investigator may enroll regardless of the time of diagnosis. * History of bleeding disorders, including gastrointestinal bleeding. Subjects with prior gastrointestinal bleeding due to the primary tumor, that is currently controlled, are allowed to participate. * Mean resting corrected QT (QTc) interval using Fridericia's formula (QTcF) \>470 ms, regardless of gender, or history of additional risk factors for torsades de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome). Patients with left bundle block or atrial fibrillation are eligible if QTc cannot be accurately calculated provided that there is no prior history of prolonged QTc. * For patients in Part B only: AST and/or ALT \>1.5 × ULN concomitant with alkaline phosphatase \>2.5 × ULN.

Treatments Being Tested

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.

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

National Cancer Center
Goyang-si, South Korea
Seoul National University Bundang Hospital (SNUBH)
Seongnam-si, South Korea
Asan Medical Center
Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07358806), the sponsor (Oscotec Inc.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07358806 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07358806?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07358806?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07358806. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07358806. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.