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

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Cohort 1:

‣ Patients with pathologically confirmed DLBCL who have not received prior anti-lymphoma therapy.

⁃ Disease stage II to IV by Ann Arbor Classification.

⁃ Life expectancy ≥ 12 months.

• Cohort 2, 3:

‣ Pathologically confirmed DLBCL patients who have received adequate first-line treatment containing CD20 monoclonal antibody and anthracyclines (such as R-CHOP-like regimen).

⁃ Relapsed or refractory to first-line R-CHOP-like regimen.

⁃ For patients who have received only one line of therapy, if the patient has not received autologous stem cell transplantation, the investigator needs to assess as unsuitable or the patient refuses intensive chemotherapy and hematopoietic stem cell transplantation.

⁃ Life expectancy ≥ 6 months.

• Patients must also meet all of the following criteria to be included in this study:

‣ All patients must provide a signed and dated written informed consent prior to any study-specific procedure, sampling, and analysis.

⁃ Patients must be ≥ 18 years of age at the time of informed consent.

⁃ ECOG status score of 0 to 2.

⁃ Presence of at least one radiologically measurable lesion in 2 perpendicular directions as assessed by CT or MRI and a positive lesion on PET/CT scan consistent with a tumor site identified by CT or MRI.

⁃ Adequate bone marrow hematopoietic reserve and organ function.

⁃ No uncontrolled medical complications.

⁃ Patients should be able to follow the relevant requirements of this study for medication and follow-up.

⁃ Willing to comply with contraceptive restrictions.

Locations
Other Locations
China
Peking University Third Hospital
NOT_YET_RECRUITING
Beijing
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Chongqing Cancer Hospital
NOT_YET_RECRUITING
Chongqing
Guangdong Provincial People's Hospital
RECRUITING
Guangzhou
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Zhujiang Hospital of Southern Medical University
RECRUITING
Guangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Anhui Provincial Cancer Hospital
RECRUITING
Hefei
Shandong Cancer Hospital & Institute
NOT_YET_RECRUITING
Jinan
Linyi Cancer Hospital
RECRUITING
Linyi
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Shanxi Cancer Hospital
NOT_YET_RECRUITING
Taiyuan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Mengling Zhong
mengling.zhong@dizalpharma.com
+86-21-61095852
Time Frame
Start Date: 2025-08-19
Estimated Completion Date: 2030-10
Participants
Target number of participants: 150
Treatments
Experimental: DZD8586 combination therapy
3 cohorts are included in this arm:~Cohort 1: Treatment naïve DLBCL patients will receive DZD8586 at the protocol defined dose level, combined with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) regimens for 6 cycles, and then DZD8586 as maintenance therapy for patients who achieved (complete response) CR or (partial response) PR after 6 cycles combination therapy.~Cohort 2: Relapsed/refractory DLBCL patients will receive DZD8586 at the protocol defined dose level, combined with R-GemOx (rituximab, gemcitabine, and oxaliplatin) regimens for 8 cycles, and then DZD8586 as maintenance therapy for patients who achieved CR or PR after 8 cycles combination therapy.~Cohort 3: Relapsed/refractory DLBCL patients will receive DZD8586 at the protocol defined dose level, combined with BR (bendamustine and rituximab) regimens for 6 cycles, and then DZD8586 as maintenance therapy for patients who achieved CR or PR after 6 cycles combination therapy.
Sponsors
Leads: Dizal Pharmaceuticals

This content was sourced from clinicaltrials.gov