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New treatment option for Solid Tumor
Official title Study to Assess the Effect of OCT-598 in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07358806
What this study is testing
What is OCT-598?
OCT-598 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Treatment with any IP or other anticancer therapy (including chemotherapy, antibody-drug conjugates, targeted agents, and immunotherapy) within 28...
- Prior clinically significant treatment-related toxicities not resolved to Grade ≤1 or baseline (per CTCAE version 5.0) except for alopecia...
- 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...
- Treatment with systemic corticosteroids at a dose of \>10 mg of prednisone or equivalent at the time of enrollment, or any other immunosuppressive...
See the full eligibility 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:
- 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...
- Docetaxel-appropriate (Part B): patients who have not received prior docetaxel in the advanced setting are eligible
- 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...
- 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...
- 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 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...
- 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...
- History of bleeding disorders, including gastrointestinal bleeding. people 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...
- For patients in Part B only: AST and/or ALT \>1.5 × ULN concomitant with alkaline phosphatase \>2.5 × ULN.
The study team makes the final eligibility decision.
Where it's taking place
- Goyang-si, South Korea
- Seongnam-si, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goyang-si, South Korea; Seongnam-si, South Korea; Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.