This is a prospective, open-label, multicenter, single-arm Phase II study designed to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT/SKB264) in combination with tagitanlimab (KL-A167) as second-line or later therapy in patients with recurrent or metastatic MSI-H/dMMR gynecological malignancies, including endometrial cancer, ovarian cancer, and cervical cancer. The primary objective is to evaluate the objective response rate (ORR) per RECIST v1.1 as assessed by the investigator. Secondary objectives include evaluating overall survival (OS), progression-free survival (PFS) per RECIST v1.1, disease control rate (DCR), duration of response (DoR), and the safety and tolerability of the combination regimen.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Sac-TMT will be administered as an intravenous (IV) infusion every 2 weeks on Day 1 of each 14-day cycle.
KL-A167 will be administered as an intravenous (IV) infusion every 2 weeks on Day 1 of each 14-day cycle. KL-A167 therapy for up to 2 years.
Qilu Hospital of Shandong University
Jinan, Shandong, China
Peking Union Medical College Hospital
Beijing, China
Objective response rate(ORR)
Ãbjective Response Rate (ÃRR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR). assessed byInvestigator based on RECiST version 1.1.
Time frame: up to 24 months
Progression-free survival(PFS)
Progression-free survival (PFS) was defned as the time from baseline to the earliest date of the frst objective documentation of progressive disease (PD) or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.
Time frame: up to 24 months
Duration of response (DoR)
Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response lPR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR was measured for responding subjects (PR or CR) only.
Time frame: up to 24 months
Disease control rate(DCR)
Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1,1,CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defned as neither suffcient shrinkage to qualify for PR nor suffcient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.
Time frame: up to 24 months
Overall survival(OS)
OS is defined as the time from enrollment to the date of death from any cause.
Time frame: up to 5 years
Incidence and severity of adverse events (AEs)
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Time frame: up to 24 months
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