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Recruiting Phase 1

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

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About this study

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.

Condition
Solid Tumor, Breast Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Gastric/Gastroesophageal Junction Cancer
Tested
OCT-598, Docetaxel
Sponsor
Oscotec Inc.

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 18

  • Minimum age: 18 years
  • Study condition: Solid Tumor, Breast Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, Prostate Cancer, Gastric/Gastroesophageal Junction Cancer
  • 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 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 17

  • 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.

Where

3 sites, 3 recruiting

National Cancer Center

Goyang-si, South Korea

Recruiting

Seoul National University Bundang Hospital (SNUBH)

Seongnam-si, South Korea

Recruiting

Asan Medical Center

Seoul, South Korea

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.