SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
Purpose
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.
Condition
- Solid Tumor
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental cohort A |
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration |
|
|
Experimental cohort B |
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration |
|
|
Experimental cohort C |
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration |
|
|
Experimental cohort D |
subjects will receive SKB264 in combination with pembrolizumab by intravenous administration |
|
Recruiting Locations
UT Health East Texas - Hope Cancer Center Tyler
Tyler, Minnesota 75702
Tyler, Minnesota 75702
More Details
- Status
- Recruiting
- Sponsor
- Klus Pharma Inc.