A Phase Ib/II, Open-label Clinical Study to Evaluate the Safety, Tolerability and Antitumor Activities of IN10018 in Combination With Standard Chemotherapy in Subjects With High-grade Serous Epithelial Ovarian Cancer
This is a phase Ib/II, open label clinical study to evaluate the safety, tolerability and antitumor activities of IN10018 in combination with standard chemotherapy in subjects with high-grade serous ovarian cancer (including fallopian tube cancer and primary peritoneum cancer, collectively defined as ovarian cancer).
• Ability to understand and willingness to sign informed consent(s). Signed informed consent must be obtained before any study specific procedures, except those procedures used as institutional standard of care falling into the protocol specified window and fulfilling study specific requirements such as tumor imaging.
• Female subjects ≥ 18 years at the time of signing informed consent.
• Histologically confirmed epithelia ovarian cancer, fallopian tube cancer or primary peritoneum cancer with the subtype limited to high-grade serous carcinoma (HGSC) only.
• Subjects with platinum-resistant disease, defined as having relapsed or progressed between 1- 6 months after completion of prior platinum-based therapy (at least 4 cycles).
• Have maximum total of 5 prior lines of systemic therapy and maximum 2 prior lines of systemic therapy following diagnosis of platinum-resistance.
• At least one measurable lesion can be accurately measured per RECIST 1.1 as assessed by investigator.
• ECOG performance status of 0 or 1.
• Life expectancy of at least 3 months as assessed by investigator.
• Availability of archival or fresh (newly obtained) tumor tissue sample during Screening Phase: Fresh tumor tissue sample obtained after most recent relapse or progression is preferred; if no sample or not sufficient number of slides can be provided or collected, a joint decision between Sponsor and investigator is needed for the enrollment of this subject.
⁃ Must have recovered from all AEs due to previous therapies to ≤ Grade 1 (CTCAE 5.0) or stable status as assessed by investigator.
⁃ Adequate bone marrow, liver, renal, and coagulation function within 5 days prior to first dose of study treatment.
⁃ A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
∙ Not a woman of childbearing potential (WOCBP) . OR
‣ A WOCBP who agrees to follow the contraceptive guidance during the treatment period and through 3 months after the last dose of study treatment.