A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
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 groupSponsors and collaborators
Source ClinicalTrials.gov