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New hope for ovarian cancer: drug combo targets resistant tumors

NCT ID NCT05551507

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2020

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    7 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Affiliated Obstetrics and Gynecology Hospital of Zhejiang University

    RECRUITING

    Hangzhou, China

  • Anyang Cancer Hospital

    RECRUITING

    Anyang, China

  • Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College

    RECRUITING

    Beijing, China

  • Fujian Cancer Hospital

    RECRUITING

    Fuzhou, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, China

  • Hunan Cancer Hospital

    RECRUITING

    Changsha, China

  • Tianjin Cancer Hospital

    RECRUITING

    Tianjin, China

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