SKB264 in Combination With Pembrolizumab in Subjects With Selected Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
SKB264: be administrated as an intravenous (IV) infusion on Day 1,15, 29 of each 42-day cycle;
Pembrolizumab: be administrated as an intravenous (IV) infusion on Day 1 of each 42-day cycle;
Study 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.
Eligibility
Primary outcome measure(s)
- 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
Trial sites (48)
| Facility | City | Region | Status |
|---|---|---|---|
| Community Clinical Research Center | Anderson | Indiana | |
| Norton Cancer Institute | Louisville | Kentucky | |
| Anne Arundel Medical Center (AAMC) | Annapolis | Maryland | |
| UT Health East Texas - Hope Cancer Center Tyler | Tyler | Minnesota | |
| Westchester Medical Center | Hawthorne | New York | |
| Texas Oncology, P.A. Amarillo, TX | Amarillo | Texas | |
| Texas Oncology, P.A. Austin, TX | Austin | Texas | |
| Oncology & Hematology Associates of Southwest Virginia, Inc. Roanoke, VA | Roanoke | Virginia | |
| Icon Cancer Centre Wesley | Auchenflower | Queensland | |
| Flinders Medical Centre | Bedford Park | Australia | |
| Wollongong Hospital | Kogarah | Australia | |
| Algemeen Ziekenhuis Klina | Brasschaat | Belgium | |
| Grand Hôpital de Charleroi - Site Notre-Dame | Charleroi | Belgium | |
| Cliniques Universitaires Saint-Luc | Woluwe-Saint-Lambert | Belgium | |
| BC Cancer - Kelowna | Kelowna | British Columbia | |
| Centre Hospitalier de l'Université de Montréal (CHUM) | Montreal | Canada | |
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | |
| Affiliated Cancer Hospital of Guangxi Medical University | Nanning | Guangxi | |
| Hubei Cancer Hospital | Wuhan | Hubei | |
| Hunan Cancer Hospital | Changsha | Hunan | |
| Jilin Cancer Hospital | Changchun | Jinlin | |
| The Second Hospital of Dalian | Dalian | Liaoning | |
| Weifang People's Hospital | Weifang | Shandong | |
| The First Affiliated Hospital of Xi'an Jiaotong University | Xi’an | Shanxi | |
| Beijing Obstetrics and Gynecology Hospital, Capital Medical University | Beijing | China | |
| Peking University First Hospital | Beijing | China | |
| The First Affiliated Hospital of Jilin University | Changchun | China | |
| Hunan Cancer Hospital | Changsha | China | |
| Chongqing Cancer Hospital | Chongqing | China | |
| Sun Yat-sen Memorial Hospital | Guangzhou | China | |
| Sun Yat-Sen University Cancer Center | Guangzhou | China | |
| The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | China | |
| Zhejiang Provincial People's Hospital | Hangzhou | China | |
| Qilu Hosptial of Qlilu University | Jinan | China | |
| Shandong Cancer Hospital | Jinan | China | |
| Nanjing Drum Tower Hospital | Nanjing | China | |
| Fudan University Shanghai Cancer Center | Shanghai | China | |
| Obstetrics and Gynecology Hospital Affiliated to Fudan University | Shanghai | China | |
| Liaoning Cancer Hospital & Institute | Shenyang | China | |
| The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | China |
+ 8 more sites — see the full list on the official registry below.
On this site
📄 Keytruda (pembrolizumab) drug profile →Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05642780 on ClinicalTrials.gov ↗ ← All trials in Australia