IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer (NCT05551507) | Clinical Trial Compass
RecruitingPhase 1/2
IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer
China150 participantsStarted 2020-07-27
Plain-language summary
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).
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events per NCI-CTCAE version 5.0.
Timeframe: Up to 24 months
2
Recommended phase 2 dose (RP2D) of the combination.
Timeframe: Up to 2 months
3
Objective response rate (ORR) as assessed by investigator.
✕. 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.
✕. Has a known previous or concurrent cancer that is distinct in primary site or histology from current ovarian cancer within 3 years prior to first dose of study treatment, except for curatively treated cancers such as cervical carcinoma in situ.
✕. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
✕. Has a history of major cardiovascular, cerebrovascular or thromboembolic diseases (e.g., congestive heart failure, acute myocardial infarction, unstable angina, stroke, transient ischemic attack, deep vein thrombosis or pulmonary embolism) within 6 months before first dose of study treatment, or has any of the following abnormality:
✕. Has known uncontrollable pleural effusion, pericardial effusion, or ascites requiring repeated drainage. Note: A small amount of ascites that can only be detected by imaging examination is allowed.