Actively Recruiting
IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer
Led by InxMed (Shanghai) Co., Ltd. · Updated on 2025-04-30
168
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, randomized, double-blind, phase II clinical study to evaluate the efficacy and safety of IN10018 in combination with PLD vs. placebo in combination with PLD in subjects with platinum-resistant recurrent ovarian cancer (including fallopian tube and primary peritoneal cancers).
CONDITIONS
Official Title
IN10018 in Combination With Pegylated Liposomal Doxorubicin (PLD) vs. Placebo in Combination With PLD for the Treatment of Platinum-resistant Recurrent Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign informed consent before study procedures
- Female aged 18 years or older at consent
- Histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal cancer of high-grade serous carcinoma subtype
- Relapse or progression during platinum therapy or within 6 months after completing at least 4 cycles of platinum-based therapy
- Up to 3 prior lines of systemic therapy allowed (excluding certain maintenance therapies)
- 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
- Recovery to Grade 1 or stable from prior therapy side effects
- Adequate bone marrow, liver, kidney, and coagulation function within 7 days before randomization
- Not pregnant, not breastfeeding, and either not a woman of childbearing potential or agree to contraception during and 3 months after treatment
You will not qualify if you...
- Major surgery or significant injury within 28 days, or diagnostic biopsies within 14 days before randomization
- Prior systemic anticancer therapy within 14 days or less than 5 half-lives before randomization
- Prior radiotherapy within 14 days before randomization (except certain palliative radiation)
- Prior treatment with any FAK inhibitor or pegylated liposomal doxorubicin
- Another cancer distinct from current ovarian cancer within 3 years, except certain treated cancers
- Active central nervous system metastases or carcinomatous meningitis
- History of major cardiovascular, cerebrovascular, or thromboembolic disease within 6 months
- Known pleural, pericardial effusion or ascites with symptoms or requiring drainage recently
- Malabsorption syndrome or inability to take oral drugs
- Uncontrolled gastrointestinal abnormalities or bleeding
- Evidence of intestinal obstruction or recurrent ileus
- Current interstitial pneumonia (except stable radiation fibrosis)
- Uncontrolled active infection
- Known HIV, active Hepatitis B or C infection
- Psychiatric or substance abuse disorders interfering with study participation
- Allergy or hypersensitivity to IN10018, PLD, or ingredients
- Prior cumulative anthracycline dose of 550 mg/m2 or more
- Recent treatment with strong inhibitors or inducers of CYP3A4, CYP2D6, or P-gp enzymes within 14 days
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Science and Peking Union Medical College
Beijing, China
Actively Recruiting
Research Team
S
Shangyu CHEN, N/A
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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