About this trial

This is a first-in-human (FIH) study to evaluate the safety and preliminary efficacy of experimental drug HDM2005 in patients with relapsed/refractory B-cell lymphoma and advanced solid tumors.

Eligibility criteria

Qualifiers

Agree to follow the study treatment protocol and visit schedule, enroll voluntarily and sign a written informed consent;

Male or female aged ≥ 18 years at the time of signing the ICF;

B-cell lymphoma: ECOG performance status of 0-2;

Advanced solid tumors: ECOG performance status of 0-1;

Disqualifiers

B-cell lymphoma: known central nervous system (CNS) involvement .

Advanced solid tumors: Patients with active brain metastases (defined as stable for < 4 weeks, or symptomatic, or requiring antiepileptic drug/hormonal therapy, or meningeal metastases);

Subjects with prior allogeneic HSCT who have developed acute graft-versus-host disease (GVHD) or persistent evidence of chronic GVHD (as manifested by ≥ Grade 2 serum bilirubin, ≥ Grade 3 skin involvement, or ≥ Grade 3 diarrhea or receiving systemic immunosuppressive therapy/prophylaxis for GVHD);

Subjects have another primary malignancy ,with the following exceptions: adequately treated non-melanoma skin cancer without evidence of disease recurrence and adequately treated carcinoma in situ without evidence of disease recurrence,et al;

Trial design

Treatments tested in this trial

  • HDM2005

Treatment groups

111 Participants
are divided into 1 treatment group

Locations

8
Henan Cancer Hospital ZhengzhouHenan, China
The First Affiliated Hospital of Soochow University SuzhouJiangsu, China
The Second Affiliated Hospital of Soochow University SuzhouJiangsu, China
The Affiliated Hospital of Xuzhou Medical University XuzhouJiangsu, China

Sponsors and collaborators

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Lead sponsor