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Platinum-resistant Ovarian CancerPhase 1/2NCT05551507

IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer

A Phase 1/2 study testing IN10018 in combination with PLD in people with Platinum-resistant Ovarian Cancer, run by InxMed (Shanghai) Co., Ltd. at 7 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Platinum-resistant Ovarian Cancer
What is being tested?
IN10018 in combination with PLD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
7 sitesChina
Study dates
27 Jul 2020to 30 Sep 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Female subjects ≥ 18 years at the time of signing informed consent.
  • Histologically confirmed epithelia ovarian cancer, fallopian tube cancer or primary peritoneum cancer with the subtype limited to high-grade serous carcinoma (HGSC) only.
  • 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).
  • Have maximum total of 5 prior lines of systemic therapy and maximum 2 prior lines of systemic therapy following diagnosis of platinum-resistance.
  • At least one measurable lesion can be accurately measured per RECIST 1.1 as assessed by investigator.
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  • ECOG performance status of 0 or 1.
  • Life expectancy of at least 3 months as assessed by investigator.
  • 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.
  • Must have recovered from all AEs due to previous therapies to ≤ Grade 1 (CTCAE 5.0) or stable status as assessed by investigator.
  • Adequate bone marrow, liver, renal, and coagulation function within 5 days prior to first dose of study treatment.
  • 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.

Who cannot join

  • 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.
  • 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.
  • Has received prior radiotherapy within 14 days prior to first dose of study treatment.
  • Has received prior treatment of any FAK inhibitor or prior treatment of PLD.
  • 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.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
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  • 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.
  • 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.
  • Has malabsorption syndrome or inability to take oral drugs.
  • Has clinically significant gastrointestinal abnormalities including uncontrolled gastrointestinal inflammatory lesions (Crohn's disease, or ulcerative colitis in active) or uncontrolled gastrointestinal bleeding.
  • Has an active infection requiring systemic therapy within 14 days prior to the first dose of study treatment.
  • Has known human immunodeficiency virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authority and/or site.
  • 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.
  • 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.
  • Has a known psychiatric or substance abuse disorder that would interfere with the subject's ability to cooperate with the requirements of the study.
  • Known allergy or hypersensitivity to IN10018 or PLD, or their ingredients.
  • Has received prior cumulative anthracycline dose of 550 mg/m2 or more.
  • 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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jack Zhang contact

86-18611511983

jack.zhang@inxmed.com

Bohong Zhang contact

86-18801955197

bohong.zhang@inxmed.com

7 sites in 1 country

China7 sites, 7 recruiting

  • Anyang Cancer Hospital

    Anyang

    Lihong Lin

    Recruiting

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

    Beijing

    Lingying WU

    Recruiting

  • Hunan Cancer Hospital

    Changsha

    Jing Wang

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou

    An Lin

    Recruiting

  • Affiliated Obstetrics and Gynecology Hospital of Zhejiang University

    Hangzhou

    Weiguo Lv

    Recruiting

  • Tianjin Cancer Hospital

    Tianjin

    Ke Wang

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Li Wang

    Recruiting

Other trials in China

About this study

Official title: 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 Epithelial Ovarian Cancer

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).

Read the detailed description

Study will evaluate IN10018 in combination with pegylated liposomal doxorubicin (PLD) in subjects with platinum-resistant recurrent ovarian cancer. All the subjects will receive combination therapy until documented progressive disease or unacceptable toxicity.

Being tested
IN10018 in combination with PLD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IN10018 in combination with PLDDrug

    Also called IN10018 add on to PLD treatment

    IN10018 in combination with PLD to treat subjects with platinum-resistant recurrent ovarian cancer

Study groups in NCT05551507
Study groupRoleWhat they receive
IN10018 in combination with PLDExperimentalIN10018 in combination with PLD in platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer or primary peritoneum cancer with the subtype limited to high-grade serous carcinoma subjects.
Receives: Drug: IN10018 in combination with PLD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events per NCI-CTCAE version 5.0.

    Incidence of Treatment-Emergent Adverse Events per NCI-CTCAE version 5.0.

    Measured: Up to 24 months

  2. Recommended phase 2 dose (RP2D) of the combination.

    Defined based on the incidence of dose limiting toxicities (DLTs).

    Measured: Up to 2 months

  3. Objective response rate (ORR) as assessed by investigator.

    ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR), as assessed by investigator per RECIST 1.1.

    Measured: Up to 24 months

Secondary outcomes (6)

  1. Objective response rate (ORR) as assessed by blinded independent central review (BICR).

    ORR is defined as the proportion of subjects with complete response (CR) and partial response (PR), as assessed by BICR per RECIST 1.1.

    Measured: Up to 24 months

  2. Duration of response (DOR) as assessed by investigator and BICR.

    DOR is defined as the time from the first occurrence of objective response to disease progression or death from any cause (whichever occurs first), as assessed by investigator and BICR per RECIST 1.1.

    Measured: Up to 24 months

  3. Disease control rate (DCR) as assessed by investigator and BICR.

    DCR is defined as the proportion of subjects with CR or PR, or stable disease, as assessed by investigator and BICR per RECIST 1.1.

    Measured: Up to 24 months

  4. Progression free survival (PFS) as assessed by investigator and BICR.

    PFS is defined as the time from start of treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as assessed by investigator and BICR per RECIST 1.1.

    Measured: Up to 24 months

  5. Overall survival (OS)

    OS is defined as the time from start of treatment to death from any cause.

    Measured: Up to 24 months

  6. CA 125 response rate per Gynecological Cancer Inter-group (GCIG) criteria.

    CA 125 response rate per GCIG criteria.

    Measured: Up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2022
  2. Study start27 Jul 2020
  3. Primary completion31 May 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05551507
Sponsor's protocol ID
IN10018-006
Status last verified
May 2026
First submitted
15 Sep 2022
Last updated
4 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IN10018 in combination with PLD in people with Platinum-resistant Ovarian Cancer, run by InxMed (Shanghai) Co., Ltd. at 7 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jack Zhang (86-18611511983, jack.zhang@inxmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events per NCI-CTCAE version 5.0. (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05551507.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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