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.
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
Absolute neutrophil count ≥1.5 × 109/L
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.
Sequential
OCT-598
DrugOCT-598 will be administered orally once daily.
Docetaxel
Combination productDocetaxel will be provided for Part B only to support the combination therapy with the standard-of-care regimen.
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Treatment groupsSee each treatment group below.
To evaluate the safety and tolerability by measuring the frequency and severity of adverse events, as assessed by CTCAE v5.0
Incidence of Dose-Limiting Toxicities (DLTs) for Determination of the Maximum Tolerated Dose (MTD)
Incidence of adverse events and dose-limiting toxicities used to determine the recommended Phase 2 dose (RP2D) of OCT-598 (PART B only)
To assess the maximum observed plasma concentration (Cmax) of OCT-598.
To evaluate the effect of food on the pharmacokinetics of OCT-598 by comparing Cmax under fed and fasted conditions.
To measure time of maximum plasma concentration (Tmax)
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