Solid Tumor
Conditions
Brief summary
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.
Interventions
DRUGSKB264
be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;
DRUGPembrolizumab
be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;
Sponsors
Myriad Genetics, Inc.
Discovery Life Sciences, LLC
Ventana Medical Systems, Inc
Frontage Laboratories, Inc.
Clario
Klus Pharma Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose limiting toxicity (DLT) and adverse events (AEs) | From subject sign the ICF to 30 days after the last dose of study treatment | Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0. |
| Objective Response Rate (ORR) | From baseline until disease progression, death or other protocol defined reason up to approximately 21 months | ORR is defined as the proportion of subjects with confirmed CR or PR as the best overall response assessed per RECIST 1.1. |
| Prostate-specific antigen (PSA) response rate (Cohort D) | From baseline until disease progression, death or other protocol defined reason up to approximately 21 months | The percentage of subjects in the analysis population who have a negative change (decrease) in PSA level of ≥ 50% measured twice ≥ 3 weeks apart |
Countries
Australia, Belgium, Canada, China, Poland, United States
Outcome results
None listed