RecruitingPhase 1Phase 2NCT07059650

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

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

Sponsor

Dizal Pharmaceuticals

Enrollment

150 participants

Start Date

Aug 19, 2025

Study Type

INTERVENTIONAL

Conditions

Diffuse Large B Cell Lymphoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing DZD8586, a new targeted drug, in combination with other treatments for people with diffuse large B-cell lymphoma (DLBCL), a common aggressive form of blood cancer. The study includes both newly diagnosed patients and those whose lymphoma has returned or stopped responding to prior treatment. **You may be eligible if...** - You have been diagnosed with DLBCL confirmed by a tissue biopsy - For newly diagnosed: you have not yet received any treatment (Cohort 1) - For relapsed/refractory: your lymphoma came back or stopped responding after standard first-line chemotherapy (Cohorts 2 and 3) - Your life expectancy is at least 12 months (for newly diagnosed) - You are in good enough health to tolerate treatment **You may NOT be eligible if...** - You have other subtypes of lymphoma that do not qualify - You have active, uncontrolled infections - You have significant heart, liver, or kidney problems - You are pregnant or breastfeeding - You have central nervous system lymphoma involvement (for some cohorts) 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

DRUGDZD8586+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.

DRUGDZD8586+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.

DRUGDZD8586+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

View Full Details on ClinicalTrials.gov

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