IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInxMed (Shanghai) Co., Ltd.

About this trial

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).

Eligibility criteria

Qualifiers

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).

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • IN10018 in combination with PLD

Treatment groups

150 Participants
are divided into 1 treatment group

Sponsors and collaborators