Actively Recruiting
Study to Assess the Effect of OCT-598 in Patients With Advanced Solid Tumors
Led by Oscotec Inc. · Updated on 2026-01-22
51
Participants Needed
3
Research Sites
101 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Study to Assess the Effect of OCT-598 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at screening
- Signed informed consent before any study procedures not part of standard care
- Life expectancy greater than 12 weeks as judged by the investigator
- Adequate organ and marrow function including neutrophils \u2265 1.5 x 10^9/L, platelets \u2265 100,000/\u03bcL, hemoglobin \u2265 9.0 g/dL, bilirubin less than 1.5 times upper limit of normal, ALT or AST less than 2.5 times upper limit of normal, and creatinine clearance \u2265 60 mL/min
- Left ventricular ejection fraction greater than 50% or within institutional normal range
- At least one measurable lesion based on RECIST 1.1
- Part A: advanced solid tumors with no effective standard therapy or inappropriate standard care per investigator
- Part B: candidates for docetaxel treatment including specific cancers (HER2-negative breast, head and neck, non-small cell lung, prostate, gastric/gastroesophageal cancer)
- Part B patients must not have received prior docetaxel in advanced setting
You will not qualify if you...
- Any anticancer therapy including chemotherapy, antibody-drug conjugates, targeted agents, or immunotherapy within 28 days or 5 half-lives before first study drug dose
- Unresolved treatment-related toxicities greater than Grade 1 except alopecia; stable Grade 2 peripheral neuropathy or controlled endocrinopathies allowed
- Prior treatment with EP2 and/or EP4 antagonists
- Major surgery or wide-field radiation within 28 days or limited palliative radiation within 7 days before first dose
- Active central nervous system metastases; asymptomatic treated brain metastases allowed if stable for at least 4 weeks without corticosteroids
- Use of systemic corticosteroids over 10 mg prednisone equivalent or other immunosuppressants within 7 days before first dose; premedication corticosteroids for chemotherapy allowed
- Pregnant, breastfeeding, or planning pregnancy during the study
- Other active malignancies within 2 years except certain cured skin, cervical, breast, or prostate cancers
- History of bleeding disorders including gastrointestinal bleeding unless controlled
- QTc interval over 470 ms or other significant cardiac risk factors unless QTc cannot be calculated but no history of prolonged QTc
- For Part B only: AST or ALT over 1.5 times upper limit of normal with alkaline phosphatase over 2.5 times upper limit of normal
AI-Screening
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Trial Site Locations
Total: 3 locations
1
National Cancer Center
Goyang-si, South Korea
Actively Recruiting
2
Seoul National University Bundang Hospital (SNUBH)
Seongnam-si, South Korea
Actively Recruiting
3
Asan Medical Center
Seoul, South Korea
Not Yet Recruiting
Research Team
S
Sungsil Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
9
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