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RECRUITING
NCT07059650
PHASE1/PHASE2

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

Sponsor: Dizal Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study will treat patients with diffuse large B-cell lymphoma (DLBCL). It will assess the anti-tumor efficacy and safety of DZD8586 combination therapy by using objective response rate and the incidence and severity of adverse events. It will also measure the levels of DZD8586 in the body when combined with immunochemotherapy regimens.

Official title: A Phase Ib/II, Multicenter Study to Evaluate the Efficacy and Safety of DZD8586 Combination Therapy in Diffuse Large B-cell Lymphoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-08-19

Completion Date

2030-10

Last Updated

2026-04-01

Healthy Volunteers

No

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.

Locations (13)

Peking University Third Hospital

Beijing, China

Hunan Cancer Hospital

Changsha, China

West China Hospital of Sichuan University

Chengdu, China

Guangdong Provincial People's Hospital

Guangzhou, China

Sun Yat-sen University Cancer Center

Guangzhou, China

Zhujiang Hospital of Southern Medical University

Guangzhou, China

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

Anhui Provincial Cancer Hospital

Hefei, China

Linyi Cancer Hospital

Linyi, China

Shanxi Cancer Hospital

Taiyuan, China

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

Wuhan, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Henan Cancer Hospital

Zhengzhou, China