Spots Global Cancer Trial Database for Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies
Official Title: A Phase I-II, First-in-Human Study of SKB264 in Patients With Locally Advanced Unresectable /Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies
Study ID: NCT04152499
Interventions
Study Description
Brief Summary: A Phase I-II, First-in-Human Study of SKB264 in Patients with Locally Advanced Unresectable/Metastatic Solid Tumors who are refractory to Available Standard Therapies. Patient must have historically documented, incurable, locally advanced or metastatic cancer that are refractory to standard therapies of one of the following types: 1. Triple negative breast cancer 2. Epithelial ovarian cancer 3. Non-small cell lung cancer 4. Gastric adenocarcinoma/Gastroesophageal junction adenocarcinoma 5. Small cell lung cancer 6. HR+/ HER2-breast cancer 7. Head and neck squamous cell carcinoma 8. Endometrial carcinoma 9. Urothelial carcinoma
Detailed Description: This is an open label, Phase I-II, first in human (FIH) study for SKB264 as monotherapy in patients who have locally advanced unresectable or metastatic solid tumor that is refractory to all standard therapies. TROP2 (trophoblast antigen 2) assessments will not be performed prior to enrollment but it will be assessed retrospectively. Confirmation of TROP2 (trophoblast antigen 2) expression by immunohistology or other means is not required, but the Sponsor will request fresh tumor biopsy or tissue specimens from archived materials for determination of TROP2 (trophoblast antigen 2) expression retrospectively. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy whose tumor is refractory to standard therapies. Patients will receive study drug as a single IV infusion at the prescribed dose level at each administration. Cycles will continue until disease progression or unacceptable toxicity. The study is divided into 2 parts (Phase I and Phase II).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California Los Angeles, Los Angeles, California, United States
Georgetown University, Washington, District of Columbia, United States
Florida Cancer Specialists and Research Institute, Sarasota, Florida, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
START MidWest, Grand Rapids, Michigan, United States
The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Providence Cancer Institute, Franz Clinic, Portland, Oregon, United States
Mary Crowley Cancer Research, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Virginia Cancer Specialists, Fairfax, Virginia, United States
The Second Hospital of Anhui Medical University, Hefei, Anhui, China
Chongqing University Cancer Hosptital, Chongqing, Chongqing, China
The First Affiliated Hospital Of Xiamen University, Xiamen, Fujian, China
Sun Yat-sen University Cancer Center, Guangzhou, Guangzhou, China
Zhejiang Cancer Hospital, Gongshu, Hangzhou, China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Wuhan Union Hospital of China, Wuhan, Hubei, China
Hunan Cancer Hospital, Changsha, Hunan, China
Shandong Cancer Hospital, Jinan, Shandong, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Hubei Cancer Hospital, Hongshan, Wuhan, China
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
ZHEJIANG University School of Medical SIR RUN RUN SHAW Hospital, Hangzhou, Zhejiang, China
Beijing Cancer Hospital, Beijing, , China
Beijing Cancer Hospital, Beijing, , China
Beijing Chao-Yang Hospital, Capital Medical University, Beijing, , China
Chinese PLA General Hospital (301 Hospital), Beijing, , China
Jilin Cancer Hospital, Changchun, , China
Hunan Cancer Hospital, Changsha, , China
Sichuan Cancer Hospital, Chengdu, , China
Chongqing University Cancer Hospital, Chongqing, , China
The Second Hospital of Dalian Medical University, Dalian, , China
Sun Yat-Sen Memorial Hospital , Sun Yat-sen University, Guangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Hunan Cancer Hospital, Hunan, , China
Jiangxi Cancer Hospital, Nanchang, , China
The First Affiliated Hospital of Nanchang University, Nanchang, , China
Jiangsu Province Hospital, Nanjing, , China
Shandong Cancer Hospital, Shandong, , China
Fudan University Shanghai Cancer Center, Shanghai, , China
Shanghai East Hospital, Shanghai, , China
Zhongshan Hospital, Fudan University, Shanghai, , China
Liaoning Cancer Hospital, Shenyang, , China
The First Hospital of China Medical University, Shenyang, , China
The Fourth Hospital of Hebei Medical University, Shijiazhuang, , China
Shanxi Provincial Cancer Hospital, Taiyuan, , China
Tianjin Cancer Hospital, Tianjin, , China
Tianjin Medical University Cancer, Tianjin, , China
Weifang People's Hospital, Weifang, , China
Hubei Cancer Hospital, Wuhan, , China
Wuhan Union Hospital of China, Wuhan, , China
Zhongnan Hospital of Wuhan University, Wuhan, , China
The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, , China
Xuzhou Central Hospital, Xuzhou, , China
Henan Cancer Hospital, Zhengzhou, , China
Contact Details
Name: Jordi Rodon Ahnert, MD, PhD
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
