Trial Title:
A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor
NCT ID:
NCT06615193
Condition:
Advanced Solid Tumors
Refractory Lymphoma
Relapsed Hematologic Malignancy
Conditions: Official terms:
Lymphoma
Hematologic Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HDM2005
Description:
HDM2005 will be administered via IV infusion.
Arm group label:
HDM2005
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Agree to follow the study treatment protocol and visit schedule, enroll voluntarily
and sign a written informed consent;
2. Male or female aged ≥ 18 years at the time of signing the ICF;
3. B-cell lymphoma: ECOG performance status of 0-2;
4. Advanced solid tumors: ECOG performance status of 0-1;
5. Life expectancy of at least 3 months;
6. Dose escalation phase: Histopathologically confirmed relapsed/refractory B-cell
lymphoma following at least 2 prior lines of systemic therapy;
7. Dose expansion phase: relapsed/refractory B-cell lymphoma and advanced or metastatic
solid tumor of specified type.
8. All subjects are required to provide archived tissue (5 unstained sections) obtained
within the previous 2 years or fresh tissue for ROR1 expression testing at the
central laboratory; in addition, relapsed/refractory lymphoma subjects are required
to provide tissue sections used for previous pathological diagnosis for pathological
consultation at the central laboratory;
9. Relapsed/refractory B-cell lymphoma: Subjects in Phase Ia dose escalation phase
should have evaluable lesions; subjects in Phase Ib dose expansion phase should have
at least 1 radiographically measurable lymph node or extranodal malignant tumor
lesion (intranodal lesion defined as having a long diameter > 1.5 cm; extranodal
lesion having a long diameter > 1.0 cm) as assessed by computed tomography
(CT)/magnetic resonance imaging (MRI) according to 2014 Lugano criteria, and a
lesion that has previously received radiotherapy is considered measurable when it
shows unequivocal progression after completion of radiotherapy;
10. Advanced solid tumors: subjects are required to have at least 1 measurable lesion
according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 ;
11. Subjects must have recovered (to ≤ Grade 1) from any AE associated with prior
anticancer therapy;
12. Subjects have adequate organ and bone marrow function;
13. Female subjects of childbearing potential should agree to use contraception methods
(e.g., intrauterine device, contraceptive pill, or condom) during the study and for
6 months after the end of the study; have a negative serum pregnancy test within 7
days before study enrollment; and male subjects should agree to use contraceptive
avoidance measures during the study and for 6 months after the end of the study.
Exclusion Criteria:
1. B-cell lymphoma: known central nervous system (CNS) involvement .
2. 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);
3. 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);
4. 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;
5. History of severe bleeding disorders ;
6. History of chronic pancreatitis or acute pancreatitis within 6 months;
7. History of interstitial lung disease, radiation pneumonitis requiring steroid
therapy, or any evidence of clinically active interstitial lung disease;
8. Patients with uncontrolled pleural effusion, pericardial effusion or ascites
requiring repeated drainage after intubation and drainage, VEGF inhibitors, platinum
and other drugs injection (subjects with stable symptoms for at least one week after
treatment can be enrolled);
9. Prior solid organ transplantation;
10. Persistent peripheral neuropathy > Grade 1 at baseline;
11. Clinically significant cardiovascular or cerebrovascular diseases;
12. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection
requiring systemic therapy (except for localized skin or nail bed fungal infection)
at enrollment;
13. Active infectious disease, such as HIV infection, active hepatitis B, active
hepatitis C (positive RNA result), active syphilis;
14. Receiving corticosteroids (prednisone equivalent more than 30 mg/day);
15. Contraindication to any component of HDM2005;
16. History of drug anaphylactic shock, severe food allergy, uncontrolled asthma/COPD;
17. Female subjects who are pregnant, lactating or planning to become pregnant during
the study;
18. Known history of mental illness or substance abuse that would impair the subject's
ability to cooperate with study requirements;
19. Prior or current evidence of any disease, treatment, or laboratory abnormality that,
in the opinion of the investigator, could affect the outcome of the study, prevent
the subject from participating in the study entirely, or is not in the subjects'
best interest.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Keshu Zhou
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengming Jin
Facility:
Name:
The Second Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Bingzong Li
Facility:
Name:
The Affiliated Hospital of Xuzhou Medical University
Address:
City:
Xuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhenyu Li
Facility:
Name:
The First Affiliated Hospital Of Nanchang University
Address:
City:
Nanchang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Fei Li
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zengjun Li
Contact backup:
Last name:
Juan Li
Facility:
Name:
The First Affiliated Hospital of Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Wenjuan Yu
Facility:
Name:
The Institute of Hematology and Blood Diseases Hospital at the Chinese Academy of Medical Sciences
Address:
City:
Tianjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Lugui Qiu
Start date:
August 12, 2024
Completion date:
February 1, 2028
Lead sponsor:
Agency:
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06615193
