Actively Recruiting
IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer
Led by InxMed (Shanghai) Co., Ltd. · Updated on 2026-05-04
150
Participants Needed
7
Research Sites
322 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and willing to sign informed consent before study procedures
- Female aged 18 years or older at consent
- Histologically confirmed high-grade serous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneum cancer
- Platinum-resistant disease with relapse or progression 1 to 6 months after prior platinum-based therapy
- No more than 5 prior systemic therapy lines and no more than 2 lines after platinum-resistance diagnosis
- At least one measurable lesion per RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Availability of archival or fresh tumor tissue sample during screening
- Recovered from previous therapy adverse events to Grade 1 or stable
- Adequate bone marrow, liver, kidney, and coagulation function within 5 days before first dose
- Female is not pregnant, not breastfeeding, and either not a woman of childbearing potential or agrees to contraceptive guidance during and 3 months after treatment
You will not qualify if you...
- Major surgery or significant injury within 28 days before first dose, or diagnostic biopsies within 14 days before first dose
- Prior systemic anticancer therapy or investigational agents within 14 days or less than 5 half-lives before first dose
- Prior radiotherapy within 14 days before first dose
- Previous treatment with any FAK inhibitor or PLD
- Other cancer distinct from current ovarian cancer within 3 years except curatively treated cervical carcinoma in situ
- Active central nervous system metastases or carcinomatous meningitis
- History of major cardiovascular, cerebrovascular, or thromboembolic events within 6 months or certain heart abnormalities
- Uncontrollable pleural, pericardial effusion, or ascites requiring repeated drainage
- Malabsorption syndrome or inability to take oral drugs
- Uncontrolled gastrointestinal inflammatory lesions or bleeding
- Active infection needing systemic therapy within 14 days before first dose
- Known HIV infection
- Known active Hepatitis B or C infection
- Any condition or abnormality interfering with study participation or results
- Psychiatric or substance abuse disorder interfering with study cooperation
- Allergy or hypersensitivity to IN10018, PLD, or their ingredients
- Prior cumulative anthracycline dose of 550 mg/m2 or more
- Systemic treatment with CYP3A4, CYP2D6, or P-gp strong inhibitors/inducers within 14 days before first dose or expected during treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Anyang Cancer Hospital
Anyang, China
Actively Recruiting
2
Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, China
Actively Recruiting
3
Hunan Cancer Hospital
Changsha, China
Actively Recruiting
4
Fujian Cancer Hospital
Fuzhou, China
Actively Recruiting
5
Affiliated Obstetrics and Gynecology Hospital of Zhejiang University
Hangzhou, China
Actively Recruiting
6
Tianjin Cancer Hospital
Tianjin, China
Actively Recruiting
7
Henan Cancer Hospital
Zhengzhou, China
Actively Recruiting
Research Team
J
Jack Zhang
CONTACT
B
Bohong Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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