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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

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

A Phase Ia/Ib, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor

A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor (NCT06615193) is a Phase 1 interventional studying Advanced Solid Tumors and Refractory Lymphoma, sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Advanced Solid Tumors, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 111 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Advanced Solid Tumors subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Agree to follow the study treatment protocol and visit schedule, enroll voluntarily and sign a written willing to sign a consent form; 2. Male or female aged ≥ 18 years at the time of signing the ICF; 3. B-cell lymphoma: You should be able to carry out daily activities with 0 level of ability (ECOG 0)-2; 4. Advanced solid tumors: You should be able to carry out daily activities with 0 level of ability (ECOG 0)-1; 5. expected to live 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 ; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

HDM2005

HDM2005 will be administered via IV infusion.

Locations (8)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, China
Shandong Cancer Hospital
Jinan, Shandong, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The Institute of Hematology and Blood Diseases Hospital at the Chinese Academy of Medical Sciences
Tianjing, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06615193), the sponsor (Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06615193 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06615193?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06615193?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06615193. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06615193. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.