NCT06615193 A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor
| NCT ID | NCT06615193 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. |
| Condition | Advanced Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 111 participants |
| Start Date | 2024-08-12 |
| Primary Completion | 2026-06-24 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 111 participants in total. It began in 2024-08-12 with a primary completion date of 2026-06-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06615193 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06615193 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06615193 currently recruiting?
Yes, NCT06615193 is actively recruiting participants. Contact the research team at hdgdzhoujun@eastchinapharm.com for enrollment information.
Where is the NCT06615193 trial being conducted?
This trial is being conducted at Zhengzhou, China, Suzhou, China, Suzhou, China, Xuzhou, China and 4 additional locations.
Who is sponsoring the NCT06615193 clinical trial?
NCT06615193 is sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. The trial plans to enroll 111 participants.