DZD8586 Combination Therapy in Patients With Diffuse Large B-cell Lymphoma (TAI-SHAN12)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

August 19, 2025

Primary Completion Date

October 31, 2030

Study Completion Date

October 31, 2030

Conditions
Diffuse Large B-Cell Lymphoma
Interventions
DRUG

DZD8586+R-CHOP

DZD8586 at the protocol defined dose level (50 mg or 75 mg, po, qd) with R-CHOP (Rituximab: 375 mg/m2, IV, d1; Cyclophosphamide: 750 mg/m2, IV, d1; Doxorubicin: 50 mg/m2, IV, d1; Vincristine: 1.4 mg/m2, IV, d1; Prednisone: 100 mg, po, d1-5) in a 21-day cycle for 6 cycles. DZD8586 (pre-defined dose level, po, qd) as maintenance therapy for CR/PR patients.

DRUG

DZD8586+R-GemOx

DZD8586 at the protocol defined dose level (50 mg or 75 mg, po, qd) with R-GemOx (Rituximab: 375 mg/m2, IV, d1; Gemcitabine: 1000 mg/m2, IV, d1; Oxaliplatin: 100 mg/m2, IV, d1) in a 21-day cycle for 8 cycles. DZD8586 (pre-defined dose level, po, qd) as maintenance therapy for CR/PR patients.

DRUG

DZD8586+BR

DZD8586 at the protocol defined dose level (50 mg or 75 mg, po, qd) with BR (Bendamustine: 90 mg/m2, IV, d1-d2; Rituximab: 375 mg/m2, IV, d1) in a 21-day cycle for 6 cycles. DZD8586 (pre-defined dose level, po, qd) as maintenance therapy for CR/PR patients.

Trial Locations (16)

Unknown

NOT_YET_RECRUITING

Peking University Third Hospital, Beijing

NOT_YET_RECRUITING

Hunan Cancer Hospital, Changsha

NOT_YET_RECRUITING

West China Hospital of Sichuan University, Chengdu

NOT_YET_RECRUITING

Chongqing Cancer Hospital, Chongqing

RECRUITING

Guangdong Provincial People's Hospital, Guangzhou

RECRUITING

Sun Yat-sen University Cancer Center, Guangzhou

RECRUITING

Zhujiang Hospital of Southern Medical University, Guangzhou

RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou

RECRUITING

Anhui Provincial Cancer Hospital, Hefei

NOT_YET_RECRUITING

Shandong Cancer Hospital & Institute, Jinan

RECRUITING

Linyi Cancer Hospital, Linyi

NOT_YET_RECRUITING

Shengjing Hospital of China Medical University, Shenyang

NOT_YET_RECRUITING

Shanxi Cancer Hospital, Taiyuan

RECRUITING

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

NOT_YET_RECRUITING

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

NOT_YET_RECRUITING

Henan Cancer Hospital, Zhengzhou

Sponsors
All Listed Sponsors
lead

Dizal Pharmaceuticals

INDUSTRY