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IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer | Clinical Trials | Clareo Health

RECRUITINGPHASE1/PHASE2

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

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

NCT05551507•InxMed (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

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).

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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.
+4 more criteria

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；
+14 more criteria

Locations (7)

Anyang Cancer Hospital

Anyang, China

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

Beijing, China

Hunan Cancer Hospital

Changsha, China

Fujian Cancer Hospital

Fuzhou, China

Affiliated Obstetrics and Gynecology Hospital of Zhejiang University

Hangzhou, China

Tianjin Cancer Hospital

Tianjin, China

Henan Cancer Hospital

Zhengzhou, China

Key Dates

Start Date

July 27, 2020

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2025

Last Updated

April 30, 2025

Enrollment

150

ESTIMATED participants

Conditions

Platinum-resistant Ovarian Cancer

Interventions

IN10018 in combination with PLD

DRUG

Contacts

Jack Zhang

CONTACT

86-18611511983 jack.zhang@inxmed.com

Bohong Zhang

CONTACT

86-18801955197 bohong.zhang@inxmed.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Efficacy & Safety of Olvi-Vec and Platinum-doublet + Bevacizumab Compared to Physician's Choice of Chemotherapy and Bevacizumab in Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

A Study of MGC026 in Participants With Advanced Solid Tumors

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