This is a multicenter, randomized, double-blind, phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers).
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 epithelial ovarian cancer, fallopian tube cancer or primary peritoneum cancer and its subtype is high-grade serous carcinoma (HGSC).
Have received platinum containing therapy and have radiological relapse or progression during platinum containing treatment or < 6 months (184 calendar days) after completion of prior platinum-based therapy (at least 4 cycles).
Has had major surgery or significant traumatic injury within 28 days prior to randomization, or diagnostic biopsies within 14 days prior to randomization.
Has received prior systemic anticancer therapy including investigational agents, such as within 14 days or less than 5 half-lives (whichever is shorter) of chemotherapy or targeted therapy, or within 28 days of immunotherapy, macromolecular drugs (eg., bevacizumab) or investigational drugs prior to randomization.
Has received prior radiotherapy within 14 days prior to randomization. Note: A 7-day washout is permitted for palliative radiation (≤ 14 days of radiotherapy) to non-central nervous system (CNS) disease.
Has received prior treatment of any FAK inhibitor or prior treatment of PLD.
Parallel
IN10018
Drug100mg QD orally (PO)
Placebo of IN10018
Drug100mg QD orally (PO)
Pegylated Liposomal Doxorubicin
Drug40 mg/m2 once every 4 weeks (Q4W) intravenously (IV)
Progression-free survival (PFS) per RECIST 1.1, as assessed by blinded independent central review (BICR), following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
PFS per RECIST 1.1, as assessed by BICR.
Overall survival (OS), following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
OS
Progression-free survival (PFS) per RECIST 1.1, as assessed by investigator , following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Defined as the proportion of subjects with complete response (CR) or partial response (PR)
Objective response rate (ORR) per RECIST 1.1, as assessed by BICR and Investigator, following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Defined as the proportion of subjects with complete response (CR) or partial response (PR)
Disease control rate (DCR) per RECIST 1.1, as assessed by BICR and Investigator, following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
Defined as the proportion of patients with CR, PR, or stable disease (SD).
CA 125 response rate per Gynecological Cancer Intergroup (GCIG) criteria, following treatment of IN10018 in combination with PLD vs. placebo in combination with PLD.
CA 125 response rate per GCIG criteria.
PK: AUC0-τ of subjects receiving IN10018 and/or PLD treatment by serial and sparse PK samplings.
Area under the concentration-time curve (AUC)
PK: Ctrough of subjects receiving IN10018 and/or PLD treatment by serial and sparse PK samplings.
Trough concentration (Ctrough)
PK: Cmax of subjects receiving IN10018 and/or PLD treatment by serial and sparse PK samplings.
PK parameters (i.e., AUC0-τ, Cmax and Ctrough) of IN10018 and PLD, and expose-response relationship of IN10018 by population PK models.
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