SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors

Klus Pharma

Status and phase: Enrolling; Phase 2

Conditions: Solid Tumor

Treatments: Drug: SKB264; Drug: Pembrolizumab

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05642780

SKB264-II-06

Details and patient eligibility

About

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,advanced endometrial cancer.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Subjects with active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis are not eligible.
2. Subjects who suffer from cardiovascular diseases of clinical significance.
3. Subjects with serious and/or uncontrolled concomitant diseases.
4. Subjects diagnosed active hepatitis B or hepatitis C.
5. Subjects have known human immunodeficiency virus (HIV) infection that is not well controlled.
6. Subjects with known active tuberculosis.
7. Known allergy or hypersensitivity to pembrolizumab or SKB264, or the excipients of pembrolizumab or SKB264.
8. Subjects with history of allogeneic tissue/solid organ transplant.
9. Subjects previously treated with TROP2 targeted therapy.
10. 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.
11. Subjects participating in another clinical study, unless it is an observational (non-intervention) clinical study or the follow-up period of an intervention study.
12. 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 5 patient groups

cohort A

Experimental group

Description:

subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Treatment:

Drug: Pembrolizumab

Drug: SKB264

cohort B

Experimental group

Description:

subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Treatment:

Drug: Pembrolizumab

Drug: SKB264

cohort C

Experimental group

Description:

subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Treatment:

Drug: Pembrolizumab

Drug: SKB264

cohort D

Experimental group

Description:

subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Treatment:

Drug: Pembrolizumab

Drug: SKB264

Cohort E

Experimental group

Description:

subjects will receive SKB264 in combination with pembrolizumab by intravenous administration

Treatment:

Drug: Pembrolizumab

Drug: SKB264