Search / Trial NCT06615193

A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor

Launched by HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. · Sep 23, 2024

Apply for Trial

Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying an experimental drug called HDM2005 to see how safe it is and whether it can help patients with certain types of cancer, specifically relapsed or refractory B-cell lymphoma and advanced solid tumors. This is a first-in-human study, meaning it’s the first time this drug is being tested in people. The trial is currently looking for participants aged 18 and older who have had previous treatments for their cancer but did not respond well or have seen their cancer return.

To be eligible for this trial, participants must agree to follow the study's rules and attend scheduled visits, and they should have a life expectancy of at least three months. They also need to have measurable cancer that can be seen on scans. Participants will be monitored closely throughout the trial and may need to provide tissue samples for testing. It’s important for potential participants to know that there are some health conditions that would exclude them from the study, such as active infections or certain other illnesses. Overall, this trial aims to gather valuable information that could lead to new treatment options for patients with challenging cancers.

Gender

ALL

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.

About Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. is a leading pharmaceutical company based in Hangzhou, China, specializing in the research, development, manufacturing, and commercialization of innovative therapeutic solutions. With a strong focus on quality and regulatory compliance, the company is committed to advancing healthcare by delivering safe and effective medications across various therapeutic areas. Leveraging state-of-the-art technology and a robust pipeline of clinical trials, Zhongmei Huadong strives to meet the evolving needs of patients and healthcare professionals globally, while fostering sustainable growth and collaboration within the pharmaceutical industry.

Locations

Suzhou, Jiangsu, China

Nanchang, Jiangxi, China

Suzhou, Jiangsu, China

Jinan, Shandong, China

Xuzhou, Jiangsu, China

Zhengzhou, Henan, China

Hangzhou, Zhejiang, China

Tianjing, , China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0