Trial Title:
IN10018 in Combination With Standard Chemotherapy in High-grade Serous Epithelial Ovarian Cancer
NCT ID:
NCT05551507
Condition:
Platinum-resistant Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IN10018 in combination with PLD
Description:
IN10018 in combination with PLD to treat subjects with platinum-resistant recurrent
ovarian cancer
Arm group label:
IN10018 in combination with PLD
Other name:
IN10018 add on to PLD treatment
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Anyang Cancer Hospital
Address:
City:
Anyang
Country:
China
Status:
Recruiting
Contact:
Last name:
Lihong Lin
Facility:
Name:
Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Lingying WU
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Contact:
Last name:
Jing Wang
Facility:
Name:
Fujian Cancer Hospital
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
An Lin
Facility:
Name:
Affiliated Obstetrics and Gynecology Hospital of Zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Weiguo Lv
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Contact:
Last name:
Ke Wang
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Li Wang
Start date:
July 27, 2020
Completion date:
December 2024
Lead sponsor:
Agency:
InxMed (Shanghai) Co., Ltd.
Agency class:
Industry
Source:
InxMed (Shanghai) Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05551507
