Actively Recruiting
A Phase Ia/Ib Open-label Dose Escalation and Expansion Study to Evaluate the Safety and Preliminary Efficacy of HDM2005 in Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumors
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2024-09-26
111
Participants Needed
8
Research Sites
83 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and early effectiveness of an experimental drug called HDM2005 in patients with relapsed or refractory B-cell lymphoma and advanced solid tumors. This is a first-in-human phase 1 study aiming to find a suitable dose and observe initial responses in these patients who have limited treatment options. The study has two parts: a dose escalation phase where participants receive increasing doses of HDM2005 through an intravenous infusion on Day 1 of repeated 21-day cycles, and a dose expansion phase where participants are given the recommended dose for further evaluation. This approach helps determine the best dose and monitors how patients respond over time. Participants will have scans such as CT or MRI to measure tumor lesions, blood tests to check drug levels and immune response, and safety assessments to monitor side effects. The study measures include dose-limiting toxicities, adverse events, and the tumor response rate. The trial may last up to approximately 3.5 years, during which participants will be closely monitored for treatment effects and safety.
CONDITIONS
Brief 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 protocol and visit schedule, enroll voluntarily, and sign informed consent
- Male or female aged 18 years or older at the time of consent
- ECOG performance status of 0-2 for B-cell lymphoma patients
- ECOG performance status of 0-1 for advanced solid tumor patients
- Life expectancy of at least 3 months
- For dose escalation: histopathologically confirmed relapsed/refractory B-cell lymphoma after at least 2 prior systemic therapies
- For dose expansion: relapsed/refractory B-cell lymphoma or advanced/metastatic solid tumor of specified type
- Provide archived tissue or fresh tissue for ROR1 expression testing
- B-cell lymphoma patients must have evaluable lesions; dose expansion patients must have at least one measurable lesion by imaging
- Advanced solid tumor patients must have at least one measurable lesion
- Recovery to grade 1 or less from any adverse event related to prior anticancer therapy
- Adequate organ and bone marrow function
- Female subjects of childbearing potential must use contraception and have negative pregnancy test; males must agree to contraceptive measures during and 6 months after study
You will not qualify if you...
- Known central nervous system involvement in B-cell lymphoma
- Active brain metastases in advanced solid tumor patients
- History of graft-versus-host disease after allogeneic stem cell transplant
- Another primary malignancy except adequately treated non-melanoma skin cancer or carcinoma in situ
- Severe bleeding disorders
- History of pancreatitis within 6 months
- Interstitial lung disease or radiation pneumonitis requiring steroids
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
- Prior solid organ transplantation
- Persistent peripheral neuropathy greater than grade 1 at baseline
- Significant cardiovascular or cerebrovascular diseases
- Active infections requiring systemic therapy including HIV, hepatitis B or C, syphilis
- Receiving corticosteroids above prednisone 30 mg/day
- Contraindication to any component of HDM2005
- History of drug anaphylaxis, severe food allergy, uncontrolled asthma or COPD
- Pregnant, lactating, or planning pregnancy during the study
- Known mental illness or substance abuse impairing participation
- Any condition that may affect study outcome or participant safety as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive escalating doses of HDM2005 via IV infusion on Day 1 of repeated 21-day cycles during dose escalation, or the recommended dose during dose expansion.
1 visit every 21 days
Duration - Up to 28 days after the last dose or until initiation of new therapy, and longer-term monitoring up to approximately 3.5 years
Participants are monitored for safety and treatment effects after the last dose, including adverse events and disease outcomes.
Visits depending on schedule for safety and efficacy assessments
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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