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

NCT05551507 | Recruiting Phase 1

• 1 other identifier: IN10018-006
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 7

Brief 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).

Conditions

Platinum-resistant Ovarian Cancer

Outcome Measures

Primary Outcomes (3)

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

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

  Up to 24 months

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

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

  Up to 2 months

• 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.

  Up to 24 months

Secondary Outcomes (6)

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

  Up to 24 months

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

  Up to 24 months

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

  Up to 24 months

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

  Up to 24 months

• Overall survival (OS)

  Up to 24 months

Study Arms (1)

IN10018 in combination with PLD

EXPERIMENTAL

IN10018 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.

Drug: IN10018 in combination with PLD

Interventions

IN10018 in combination with PLD DRUG

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

Also known as: IN10018 add on to PLD treatment

IN10018 in combination with PLD

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• InxMed (Shanghai) Co., Ltd.: lead

Study Sites (7)

Anyang Cancer Hospital

Anyang, China

RECRUITING

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

Beijing, China

RECRUITING

Hunan Cancer Hospital

Changsha, China

RECRUITING

Fujian Cancer Hospital

Fuzhou, China

RECRUITING

Affiliated Obstetrics and Gynecology Hospital of Zhejiang University

Hangzhou, China

RECRUITING

Tianjin Cancer Hospital

Tianjin, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

MeSH Terms

Interventions

1-dodecylpyridoxal

Study Officials

• Lingying Wu

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jack Zhang

CONTACT

86-18611511983; jack.zhang@inxmed.com

Bohong Zhang

CONTACT

86-18801955197; bohong.zhang@inxmed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 22, 2022
• Study Start: July 27, 2020
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-05

Locations

CN (7)