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).
Has had major surgery or significant traumatic injury within 28 days prior to first dose of study treatment, or diagnostic biopsies within 14 days prior to first dose of study treatment.
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, prior to first dose of study treatment.
Has received prior radiotherapy within 14 days prior to first dose of study treatment.
Has received prior treatment of any FAK inhibitor or prior treatment of PLD.
Single group
IN10018 in combination with PLD
DrugIN10018 in combination with PLD to treat subjects with platinum-resistant recurrent ovarian cancer
Incidence of Treatment-Emergent Adverse Events per NCI-CTCAE version 5.0.
Incidence of Treatment-Emergent Adverse Events per NCI-CTCAE version 5.0.
Recommended phase 2 dose (RP2D) of the combination.
Defined based on the incidence of dose limiting toxicities (DLTs).
Objective response rate (ORR) as assessed by investigator.
ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR), as assessed by investigator per RECIST 1.1.
Objective response rate (ORR) as assessed by blinded independent central review (BICR).
ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR), as assessed by BICR per RECIST 1.1.
Duration of response (DOR) as assessed by investigator and BICR.
DOR is defined as the time from the first occurrence of objective response to disease progression or death from any cause (whichever occurs first), as assessed by investigator and BICR per RECIST 1.1.
Disease control rate (DCR) as assessed by investigator and BICR.
DCR is defined as the proportion of subjects with CR or PR, or stable disease, as assessed by investigator and BICR per RECIST 1.1.
Progression free survival (PFS) as assessed by investigator and BICR.
PFS is defined as the time from start of treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as assessed by investigator and BICR per RECIST 1.1.
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