Actively Recruiting
A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2024-09-26
111
Participants Needed
8
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to follow the study treatment plan and visit schedule and provide informed consent
- Male or female aged 18 years or older at enrollment
- For B-cell lymphoma: ECOG performance status of 0 to 2
- For advanced solid tumors: ECOG performance status of 0 to 1
- Life expectancy of at least 3 months
- Dose escalation phase: relapsed/refractory B-cell lymphoma confirmed after at least two prior systemic therapies
- Dose expansion phase: relapsed/refractory B-cell lymphoma or advanced/metastatic solid tumor of specified types
- Provide archived or fresh tissue samples for ROR1 expression testing
- For lymphoma: must have evaluable lesions or measurable lymph node or tumor lesions as defined by imaging criteria
- For solid tumors: must have at least one measurable lesion per RECIST V1.1
- Recovered to Grade 1 or less from prior anticancer therapy side effects
- Adequate organ and bone marrow function
- Female subjects of childbearing potential must agree to use contraception during and for 6 months after the study, and have a negative pregnancy test; male subjects must agree to contraception use during and 6 months after the study
You will not qualify if you...
- Known central nervous system involvement in B-cell lymphoma
- Active brain metastases in solid tumor patients unless stable for 4 weeks and asymptomatic
- Prior allogeneic stem cell transplant with active or significant graft-versus-host disease
- Other primary malignancies except adequately treated non-melanoma skin cancer or carcinoma in situ without recurrence
- History of severe bleeding disorders
- History of pancreatitis within 6 months
- History or evidence of active interstitial lung disease or radiation pneumonitis requiring steroids
- Uncontrolled fluid buildup in chest, heart sac, or abdomen requiring repeated drainage unless stable for at least one week
- Prior solid organ transplant
- Peripheral neuropathy greater than Grade 1 at baseline
- Significant cardiovascular or cerebrovascular disease
- Active infections requiring systemic therapy, including HIV, active hepatitis B or C, or active syphilis
- Use of corticosteroids above 30 mg prednisone equivalent per day
- Contraindication to any component of HDM2005
- History of severe allergic reactions, uncontrolled asthma, or COPD
- Pregnant or breastfeeding women or those planning pregnancy during the study
- History of mental illness or substance abuse affecting study participation
- Other diseases or conditions that could affect study outcome or participation as per investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Henan Cancer Hospital
Zhengzhou, Henan, China
Not Yet Recruiting
2
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
3
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
4
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Actively Recruiting
5
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Not Yet Recruiting
6
Shandong Cancer Hospital
Jinan, Shandong, China
Not Yet Recruiting
7
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
8
The Institute of Hematology and Blood Diseases Hospital at the Chinese Academy of Medical Sciences
Tianjing, China
Actively Recruiting
Research Team
J
Jun Zhou, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here