1\. This is a multi-center clinical study to evaluate dual mTORC1/2 inhibitor (ATG 008) or selective inhibitor of nuclear export compound (ATG-010) in combination with chemotherapy in patients with relapsed or metastatic ovarian cancer, endometrial cancer, and cervical cancer.
This is a multi-center clinical study to evaluate dual mTORC1/2 inhibitor (ATG 008) or selective inhibitor of nuclear export compound (ATG-010) in combination with chemotherapy in patients with relapsed or metastatic ovarian cancer, endometrial cancer, and cervical cancer. And two cohorts of ATG-008 30 mg QD or ATG-010 80 mg QW in combination with chemotherapy will enroll subjects with platinum-sensitive ovarian cancer, platinum-resistant ovarian cancer, endometrial cancer, and cervical cancer, with about 8-12 subjects in either cohort. A total of about 64-96 subjects plan to be enrolled.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
Objective response rate(ORR)
Objective response rate(ORR)
Time frame: 26 months
Time to response(TTR)
Evaluated by investigators according to RECIST 1.1
Time frame: 26 months
Duration of Response(DOR)
Evaluated by investigators according to RECIST 1.1
Time frame: 26 months
Disease control rate(DCR)
Evaluated by investigators according to RECIST 1.1
Time frame: 26 months
Overall Survival(OS)
The estimates of Kaplan-Meier
Time frame: 26 months
Progression-Free Survival(PFS)
Evaluated by investigators according to RECIST 1.1
Time frame: 26 months
The incidence,severity,and causality of AE,SAE
To evaluate the safety and tolerability of ATG-008 or ATG-010 in
Time frame: 26 months
EORTC-QLQ-C30
To evaluate the safety and tolerability of ATG-008 or ATG-010 in
Time frame: 26 months
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