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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
IN10018 in combination with PLD to treat subjects with platinum-resistant recurrent ovarian cancer
Anyang Cancer Hospital
Anyang, China
RECRUITINGCancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, China
RECRUITINGHunan Cancer Hospital
Changsha, China
Incidence of Treatment-Emergent Adverse Events per NCI-CTCAE version 5.0.
Incidence of Treatment-Emergent Adverse Events per NCI-CTCAE version 5.0.
Time frame: Up to 24 months
Recommended phase 2 dose (RP2D) of the combination.
Defined based on the incidence of dose limiting toxicities (DLTs).
Time frame: 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.
Time frame: Up to 24 months
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.
Time frame: Up to 24 months
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.
Time frame: Up to 24 months
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.
Time frame: Up to 24 months
Progression free survival (PFS) as assessed by investigator and BICR.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Fujian Cancer Hospital
Fuzhou, China
RECRUITINGAffiliated Obstetrics and Gynecology Hospital of Zhejiang University
Hangzhou, China
RECRUITINGTianjin Cancer Hospital
Tianjin, China
RECRUITINGHenan Cancer Hospital
Zhengzhou, China
RECRUITINGPFS 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.
Time frame: Up to 24 months
Overall survival (OS)
OS is defined as the time from start of treatment to death from any cause.
Time frame: Up to 24 months
CA 125 response rate per Gynecological Cancer Inter-group (GCIG) criteria.
CA 125 response rate per GCIG criteria.
Time frame: Up to 24 months