SKB264 in Combination With Pembrolizumab in Subjects With... | NCT05642780

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cohort A	Experimental	subjects will receive SKB264 in combination with pembrolizumab by intravenous administration	Drug: SKB264 Drug: Pembrolizumab
cohort B	Experimental	subjects will receive SKB264 in combination with pembrolizumab by intravenous administration	Drug: SKB264 Drug: Pembrolizumab
cohort C	Experimental	subjects will receive SKB264 in combination with pembrolizumab by intravenous administration	Drug: SKB264 Drug: Pembrolizumab
cohort D	Experimental	subjects will receive SKB264 in combination with pembrolizumab by intravenous administration	Drug: SKB264 Drug: Pembrolizumab
Cohort E	Experimental	subjects will receive SKB264 in combination with pembrolizumab by intravenous administration	Drug: SKB264 Drug: Pembrolizumab

Name	Type	Description	Arm Group Labels	Other Names
SKB264	Drug	be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;	Cohort E cohort A cohort B cohort C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Dose limiting toxicity (DLT) and adverse events (AEs)	Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.	From subject sign the ICF to 30 days after the last dose of study treatment
Objective Response Rate (ORR)	ORR is defined as the proportion of subjects with confirmed CR or PR as the best overall response assessed per RECIST 1.1.	From baseline until disease progression, death or other protocol defined reason up to approximately 21 months
Prostate-specific antigen (PSA) response rate (Cohort D)	The percentage of subjects in the analysis population who have a negative change (decrease) in PSA level of ≥ 50% measured twice ≥ 3 weeks apart	From baseline until disease progression, death or other protocol defined reason up to approximately 21 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 .
Subjects with expected survival ≥ 3 months.
Cohort A: Subjects with recurrent or metastatic cervical cancer
Cohort B: Subjects with locally advanced or metastatic urothelial carcinoma
Cohort C: Subjects with recurrent ovarian cancer
Cohort D: Subjects with metastatic prostate cancer
Subjects have at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
Subjects able to provide tumor blocks or slides for biomarker test.
Subjects have relatively good organ function and bone marrow function.
Subjects must have recovered from all toxicities from previous therapy with the exception of toxicities not considered a safety risk.
Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Subject is capable of giving signed informed consent.
Cohort E: Subjects with advanced endometrial cancer.

Exclusion Criteria:

Subjects with active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis are not eligible.
Subjects who suffer from cardiovascular diseases of clinical significance.
Subjects with serious and/or uncontrolled concomitant diseases.
Subjects diagnosed active hepatitis B or hepatitis C.
Subjects have known human immunodeficiency virus (HIV) infection that is not well controlled.
Subjects with known active tuberculosis.
Known allergy or hypersensitivity to pembrolizumab or SKB264, or the excipients of pembrolizumab or SKB264.
Subjects with history of allogeneic tissue/solid organ transplant.
Subjects previously treated with TROP2 targeted therapy.
Subjects who are vaccinated with live vaccine within 30 days before the first dose, or plan to be vaccinated with live vaccine during the study period.
Subjects participating in another clinical study, unless it is an observational (non-intervention) clinical study or the follow-up period of an intervention study.
The Investigator considers other situations that will interfere with the evaluation of the study intervention or the safety of the subjects or the interpretation of the results of the study.

Facility	Status	City	State	ZIP	Country	Contacts
Community Clinical Research Center		Anderson	Indiana	46013	United States
Norton Cancer Institute