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NOT YET RECRUITING
NCT07738757
PHASE2

SKB264 Plus KL-A167 in MSI-H/dMMR Advanced Gynecological Malignancies

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase II Study of Sacituzumab Tirumotecan (Sac-TMT/SKB264) in Combination With Tagitanlimab (KL-A167) as Second-Line or Later Therapy for MSI-H/dMMR Advanced Gynecological Malignancies: An Open-Label, Single-Arm, Multicenter Exploratory Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2026-09-01

Completion Date

2029-12-30

Last Updated

2026-07-31

Healthy Volunteers

No

Interventions

DRUG

Sacituzumab Tirumotecan (Sac-TMT)

Sac-TMT will be administered as an intravenous (IV) infusion every 2 weeks on Day 1 of each 14-day cycle.

DRUG

Tagitanlimab

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.

Locations (2)

Qilu Hospital of Shandong University

Jinan, Shandong, China

Peking Union Medical College Hospital

Beijing, China