The goal of this clinical trial is to learn if the therapy of JSKN033 plus chemotherapy with or with bevacizumab is safe to treat patients with advanced cervical cancer. It will also learn about the antitumor activity and pharmacokinetic/ pharmacodynamic profiles of this therapy.
This is an open-label, multicenter, Phase II clinical study conducted in China to evaluate the safety and efficacy of JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab in patients with advanced cervical cancer. The study consists of two phases: a safety run-in phase and a dose expansion phase. Enrolled subjects are patients with persistent, recurrent, or metastatic cervical cancer who have not received prior systemic therapy for recurrent or metastatic disease. All subjects will receive treatment with JSKN033 + cisplatin/carboplatin ± bevacizumab. All enrolled subjects will continue treatment until meeting any of the following treatment termination criteria: disease progression, intolerable toxicity, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, early study termination, or other criteria specified in the protocol for treatment termination, whichever occurs first.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
JSKN033 in combination with platinum-based chemotherapy with or without bevacizumab at selected dose levels according to protocol
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Frequency and severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: 21 days from the first dose
Frequency and severity of Treatment-Related Adverse Events (TRAEs)
Time frame: 21 days from the first dose
Frequency and severity of Serious Adverse Events (SAEs)
Time frame: 21 days from the first dose
Objective Response Rate (ORR) as assessed by the investigator and IRC per RECIST 1.1.
Time frame: From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months.
Disease Control Rate (DCR)
Time frame: From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months.
Time to Response (TTR)
Time frame: From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 12 months
Duration of Response (DoR)
Time frame: From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 24 months.
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Progression-Free Survival (PFS) as assessed by the investigator and IRC per RECIST 1.1
Time frame: From the first study drug dose, until: disease progression per RECIST 1.1; initiation of new anti-tumor treatment; withdrawal of informed consent; death; loss to follow-up; or study termination, whichever comes first. Assessed at approximately 24 months.
Overall Survival (OS)
Time frame: Assessed at approximately 24 months
Maximum plasma concentration (Cmax) of JSKN033
Time frame: From the enrollment until the end of study. Assessed up to 24 months.
Time to Cmax (Tmax) of JSKN033
Time frame: From the enrollment until the end of study. Assessed up to 24 months.
Trough concentration (Ctrough) of JSKN033
Time frame: From the enrollment until the end of study. Assessed up to 24 months.
Area under the plasma concentration-time curve of JSKN033
Time frame: From the enrollment until the end of study. Assessed up to 24 months.
Volume of distribution (Vz/F) of JSKN033
Time frame: From the enrollment until the end of study. Assessed up to 24 months.
Elimination half-life (t1/2) and clearance (CL/F) of JSKN033
Time frame: From the enrollment until the end of study. Assessed up to 24 months.
Accumulation index of JSKN033
Time frame: From the enrollment until the end of study. Assessed up to 24 months.
Mean residence time of JSKN033
Time frame: From the enrollment until the end of study. Assessed up to 24 months.
Incidence of anti-drug antibodies (ADA) of JSKN033
Time frame: From the enrollment until the end of study. Assessed up to 24 months.