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RECRUITING
NCT04390737
PHASE1/PHASE2

Evaluate the Safety and Clinical Activity of HH2853

Sponsor: Haihe Biopharma Co., Ltd.

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter, first-in-human phase I/II study which is composed of 3 parts: phase I dose escalation, phase I dose extension and phase II. HH2853 will be administered orally on a continuous BID schedule on a continuous 28-day treatment cycle.

Official title: A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of HH2853 in Patients With Relapsed/Refractory Non-Hodgkin's Lymphomas or Advanced Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

254

Start Date

2020-09-08

Completion Date

2028-12-31

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

DRUG

HH2853 Tablets

Proposed daily dose (BID): 50mg, 100mg, 200mg, 400mg, 600mg, 800mg, 1000mg. It is possible for additional and/or intermediate dose levels to be added during the course of the study. Cohorts may be added at any dose level below the MTD in order to better understand safety, PK or PD.

Locations (25)

Mayo Clinic

Phoenix, Arizona, United States

Mayo Clinic

Jacksonville, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

NEXT Oncology

San Antonio, Texas, United States

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Jishuitan Hospital

Beijing, Beijing Municipality, China

Sun Yat-Sen University Cancer Hospital

Guangzhou, Guangdong, China

Affiliated Tumor Hospital of Guangxi Medical University

Nanning, Guangxi, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, China

Liaoning Cancer Hospital&Institute

Shenyang, Liaoning, China

Shengjing Hospital Of China Medical University

Shenyang, Liaoning, China

Linyi Tumor Hospital

Linyi, Shandong, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Beijing Cancer Hospital

Beijing, China

Sun Yat-Sen University Cancer Hospital

Guangzhou, China