Phase I-II, FIH, TROP2 ADC, Advanced Unresectable/Metastatic Solid Tumors, Refractory to Standard Therapies (KL264-01)

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

1,410

Participants

Timeline

Start Date

February 28, 2020

Primary Completion Date

December 31, 2025

Study Completion Date

July 16, 2026

Conditions
Epithelial Ovarian CancerGastric AdenocarcinomaGastroesophageal Junction AdenocarcinomaUrothelial CarcinomaNon-Small Cell Lung CancerSmall-Cell Lung CancerEndometrial CarcinomaHead and Neck Squamous Cell CarcinomaBreast CancerCervical Cancer
Interventions
DRUG

SKB264

SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.

Trial Locations (109)

22031

Virginia Cancer Specialists, Fairfax

34232

Florida Cancer Specialists and Research Institute, Sarasota

49546

START MidWest, Grand Rapids

73104

The University of Oklahoma Health Sciences Center, Oklahoma City

74146

Oklahoma Cancer Specialists and Research Institute, LLC, Tulsa

75230

Mary Crowley Cancer Research, Dallas

77030

MD Anderson Cancer Center, Houston

90404

University of California Los Angeles, Los Angeles

91204

Los Angeles Hematology Oncology Medical Group, Glendale

97213

Providence Cancer Institute, Franz Clinic, Portland

Unknown

Princess Margaret Cancer Centre, Toronto

Sunnybrook Research Institute, Toronto

MUHC,Glen - Women's Health Research Unit, Montreal

Centro de Estudios Clínicos SAGA, Providencia

Centro de Investigacion Clinica Bradford Hill, Santiago

Pontificia Universidad Catolica de Chile - CICUC, Santiago

The First Affiliated Hospital of Bengbu Medical University, Bengbu

Anhui Cancer Hospital, Hefei

AnHui Provincial Cancer Hospital, Hefei

The First Affiliated Hospital of Anhui Medical University, Hefei

The First Affiliated Hospital of USTC Anhui Provincial Hospital, Hefei

The Second Hospital of Anhui Medical University, Hefei

Beijing Cancer Hospital, Beijing

Beijing Chao-Yang Hospital, Capital Medical University, Beijing

Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing

Beijing Tongren Hospital, Capital Medical University, Beijing

Chinese PLA General Hospital (301 Hospital), Beijing

Peking University Third Hospital, Beijing

Chongqing University Cancer Hospital, Chongqing

Chongqing University Cancer Hosptital, Chongqing

900TH Hospital of Joint Logistics Support Force, Fuzhou

Fujian Cancer Hospital, Fuzhou

Fujian Medical University Uion Hospital, Fuzhou

The First Affiliated Hospital Of Xiamen University, Xiamen

The First Hospital of Lanzhou University, Lanzhou

Affiliated Hospital of Guangdong Medical University, Guangzhou

Guangdong Provincial People's Hospital, Guangzhou

Sun Yat-Sen Memorial Hospital , Sun Yat-sen University, Guangzhou

Sun Yat-sen Memorial Hospital, Sun Yat-sen University, Guangzhou

Sun Yat-sen University Cancer Center, Guangzhou

Sun Yat-sen University Cancer prevention Center, Guangzhou

The Second Affiliated Hospital of Guilin Medical University, Guilin

Guangxi Medical University Cancer Center, Nanning

Hainan General Hospital, Haikou

The First Affiliated Hospital of Hainan Medical University, Haikou

The Fourth Hospital of Hebei Medical University, Shijiazhuang

Harbin Medical University Cancer Hospital, Harbin

Anyang City Cancer Hospital, Anyang

The First Affiliated Hospital of Henan University of Science and Technology, Luoyang

Nanyang Center Hospital, Nanyang

The First Affiliated Hospital of Xinxiang Medical College, Xinxiang

Henan Cancer Hospital, Zhengzhou

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

Zhengzhou Central Hospital, Zhengzhou

Hubei Cancer Hospital, Wuhan

Tongji Hospital Tongji Medical College Huazhong University Of Science And Technology, Wuhan

Union Hospital Tongji Medical College Huazhong University Of Science And Technology, Wuhan

Wuhan Union Hospital of China, Wuhan

Zhongnan Hospital of Wuhan University, Wuhan

Xiangyang Central Hospital, Xiangyang

Hunan Cancer Hospital, Changsha

The Second Xiangya Hospital of Central South University, Changsha

Xiangya Hospital Central South University, Changsha

Xiangya Hospital of Central South University, Changsha

The first people's hospital of Lianyungang, Lianyungang

Jiangsu Province Hospital, Nanjing

Nanjing Drum Tower Hospital, Nanjing

Xuzhou Central Hospital, Xuzhou

Jiangxi Cancer Hospital, Nanchang

The First Affiliated Hospital of Nanchang University, Nanchang

First Hospital of Jilin University, Changchun

Jilin Cancer Hospital, Changchun

The Second Hospital of Dalian Medical University, Dalian

Liaoning Cancer Hospital, Shenyang

Shengjing Hospital of China Medical University, Shenyang

The First Hospital of China Medical University, Shenyang

The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an

Affiliated Hospital of Binzhou Medical College, Binzhou

Jinan Central Hospital, Jinan

Shandong Cancer Hospital, Jinan

Affiliated Hospital of Jining Medical College, Jining

Weifang People's Hospital, Weifang

Fudan University Shanghai Cancer Center, Shanghai

Obstetrics&Gynecology Hospital of Fudan University, Shanghai

Shanghai East Hospital, Shanghai

Shanghai General Hospital, Shanghai

Zhongshan Hospital, Fudan University, Shanghai

Shanxi Cancer Hospital, Taiyuan

Shanxi Provincial Cancer Hospital, Taiyuan

Sichuan Cancer Hospital, Chengdu

West China Hospital of Sichuan University, Chengdu

Neijiang Second People's Hospital, Neijiang

Yibin Second People's Hospital, Yibin

The Second Hospital of Tianjin Medical University, Tianjin

Tianjin Medical University Cancer Institute and Hospital, Tianjin

Zhejiang Cancer Hospital, Hangzhou

Zhejiang University School of Medical Sir Run Run Shaw Hospital, Hangzhou

Taizhou Hospital of Zhejiang Province, Taizhou

Seoul National University Bundang Hospital, Seongnam-si

Inje University Haeundae Paik Hospital, Busan

Kyungpook National University Chilgok Hospital, Daegu

National Cancer Center, Goyang-si

CHA Bundang Medical Center, CHA University, Gyeonggi-do

Gachon University Gil Medical Center, Incheon

Asan Medical Center, Seoul

Gangnam Severance Hospital, Yonsei University Health System, Seoul

Seoul National University Hospital, Seoul

Severance Hospital, Yonsei University Health System, Seoul

Gazi University Medical Faculty, Yenimahalle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Klus Pharma Inc.

INDUSTRY