RecruitingPhase 1Phase 2NCT04390737

Evaluate the Safety and Clinical Activity of HH2853

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

Sponsor

Haihe Biopharma Co., Ltd.

Enrollment

254 participants

Start Date

Sep 8, 2020

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor Peripheral T Cell Lymphoma FL Lymphoma Epithelioid Sarcoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests HH2853, a new drug that targets a gene-regulating protein (EZH2) involved in certain cancers, in people with specific types of blood cancers or solid tumors. It is being tested in people whose cancer has specific genetic mutations or characteristics that suggest EZH2 may be driving their disease. **You may be eligible if...** - You are 18 or older - You have relapsed or treatment-resistant follicular lymphoma, diffuse large B-cell lymphoma, peripheral T-cell lymphoma, or epithelioid sarcoma, or an advanced solid tumor with specific genetic features (EZH2 mutation, INI1 deficiency, BAP1 deficiency, ARID1A mutation, or SMARCA4 mutation) - You have received prior standard treatments and your cancer has progressed - Your overall health is reasonably good (ECOG 0-1) and major organ function is adequate - Your expected survival is at least 3 months **You may NOT be eligible if...** - You have had cancer-directed therapy within the past 4 weeks - You have active brain metastases that are unstable or worsening - You have had a prior stem cell transplant - You have HIV, active hepatitis B or C - You have another active cancer - You have had prior treatment with EZH2 or EZH1/2 inhibitors - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHH2853 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

View Full Details on ClinicalTrials.gov

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NCT04390737

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