NCT05551507 IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer
| NCT ID | NCT05551507 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | InxMed (Shanghai) Co., Ltd. |
| Condition | Platinum-resistant Ovarian Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2020-07-27 |
| Primary Completion | 2025-12-31 |
Trial Parameters
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Brief 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).
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Female subjects ≥ 18 years at the time of signing informed consent. 3. Histologically confirmed epithelia ovarian cancer, fallopian tube cancer or primary peritoneum cancer with the subtype limited to high-grade serous carcinoma (HGSC) only. 4. 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). 5. Have maximum total of 5 prior lines of systemic therapy and maximum 2 prior lines of systemic therapy following diagnosis of platinum-resistance. 6. At least one measurable lesion can be accurately measured per RECIST 1.1 as assessed b
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