SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of combination of SKB264 and Pembrolizumab in patients with selected solid tumors including cervical cancer, urothelial cancer, ovarian cancer, prostate cancer.

Official Title
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A Multicenter, Open-label, Phase 2, Basket Study to Evaluate the Efficacy and Safety of SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors

Conditions
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Solid Tumor

Intervention / Treatment
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* Drug: SKB264
* Drug: Pembrolizumab


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cohort A<br>subjects will receive SKB264 in combination with pembrolizumab by intravenous administration | Drug: SKB264<br>* be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;<br>Drug: Pembrolizumab<br>* be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;<br>* Other names: Keytruda;|
| Experimental: cohort B<br>subjects will receive SKB264 in combination with pembrolizumab by intravenous administration | Drug: SKB264<br>* be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;<br>Drug: Pembrolizumab<br>* be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;<br>* Other names: Keytruda;|
| Experimental: cohort C<br>subjects will receive SKB264 in combination with pembrolizumab by intravenous administration | Drug: SKB264<br>* be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;<br>Drug: Pembrolizumab<br>* be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;<br>* Other names: Keytruda;|
| Experimental: cohort D<br>subjects will receive SKB264 in combination with pembrolizumab by intravenous administration | Drug: SKB264<br>* be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;<br>Drug: Pembrolizumab<br>* be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;<br>* Other names: Keytruda;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |