New hope for ovarian cancer: drug combo targets resistant tumors
NCT ID NCT05551507
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new drug called IN10018 combined with standard chemotherapy in people with a tough-to-treat type of ovarian cancer that no longer responds to platinum-based drugs. About 150 adults will take part to see if the combination is safe and shrinks tumors. The goal is to better control the disease, not to cure it.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 150 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2020
- Expected to finish
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Sep 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 by investigator. 7. ECOG performance status of 0 or 1. 8. Life expectancy of at least 3 months as assessed by investigator. 9. Availability of archival or fresh (newly obtained) tumor tissue sample during Screening Phase: Fresh tumor tissue sample obtained after most recent relapse or progression is preferred; if no sample or not sufficient number of slides can be provided or collected, a joint decision between Sponsor and investigator is needed for the enrollment of this subject. 10. Must have recovered from all AEs due to previous therapies to ≤ Grade 1 (CTCAE 5.0) or stable status as assessed by investigator. 11. Adequate bone marrow, liver, renal, and coagulation function within 5 days prior to first dose of study treatment. 12. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: * Not a woman of childbearing potential (WOCBP) . OR * A WOCBP who agrees to follow the contraceptive guidance during the treatment period and through 3 months after the last dose of study treatment. Exclusion Criteria: 1. 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. 2. 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. 3. Has received prior radiotherapy within 14 days prior to first dose of study treatment. 4. Has received prior treatment of any FAK inhibitor or prior treatment of PLD. 5. 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. 6. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 7. 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: * QTc interval \> 480 msec; * Left ventricular ejection fraction (LVEF) \< 50%; * New York Heart Association (NYHA) functional classification ≥ Grade 2; * Clinically significant arrhythmia; * Uncontrolled hypertension; * Other clinically significant heart diseases. 8. 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. 9. Has malabsorption syndrome or inability to take oral drugs. 10. Has clinically significant gastrointestinal abnormalities including uncontrolled gastrointestinal inflammatory lesions (Crohn's disease, or ulcerative colitis in active) or uncontrolled gastrointestinal bleeding. 11. Has an active infection requiring systemic therapy within 14 days prior to the first dose of study treatment. 12. Has known human immunodeficiency virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority and/or site. 13. Has known active Hepatitis B or Hepatitis C virus infection. Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority and/or site. 14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 15. Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study. 16. Known allergy or hypersensitivity to IN10018 or PLD, or their ingredients. 17. Has received prior cumulative anthracycline dose of 550 mg/m2 or more. 18. Has received systemic treatment of CYP3A4, CYP2D6 or P-gp strong inhibitors/inducers within 14 days prior to the first dose of study treatment, or anticipation of the systemic treatment of these drugs during Treatment Phase.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
7 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Obstetrics and Gynecology Hospital of Zhejiang University
RECRUITINGHangzhou, China
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Anyang Cancer Hospital
RECRUITINGAnyang, China
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Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
RECRUITINGBeijing, China
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Fujian Cancer Hospital
RECRUITINGFuzhou, China
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Henan Cancer Hospital
RECRUITINGZhengzhou, China
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Hunan Cancer Hospital
RECRUITINGChangsha, China
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Tianjin Cancer Hospital
RECRUITINGTianjin, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a Patient's own immune cells fight ovarian cancer?
- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- Can a pill shrink Hard-to-Treat ovarian tumors?
- Can a new drug combo keep ovarian cancer from coming back?
- New drug takes aim at ovarian cancers that resist platinum chemotherapy
- Can a targeted drug duo hold off ovarian cancer's return?