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New treatment option for Advanced Solid Tumors
Official title A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor
ClinicalTrials.gov ID: NCT06615193
What this study is testing
What is HDM2005?
HDM2005 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Agree to follow the study treatment protocol and visit schedule, enroll voluntarily and sign a written informed consent;
- Male or female aged ≥ 18 years at the time of signing the ICF;
- B-cell lymphoma: ECOG performance status of 0-2;
- Advanced solid tumors: ECOG performance status of 0-1;
- Life expectancy of at least 3 months;
You likely can't join if
- B-cell lymphoma: known central nervous system (CNS) involvement .
- Advanced solid tumors: Patients with active brain metastases (defined as stable for \< 4 weeks, or symptomatic, or requiring antiepileptic...
- people with prior allogeneic HSCT who have developed acute graft-versus-host disease (GVHD) or persistent evidence of chronic GVHD (as manifested by...
- people have another primary malignancy ,with the following exceptions: adequately treated non-melanoma skin cancer without evidence of disease...
- History of severe bleeding disorders ;
- History of chronic pancreatitis or acute pancreatitis within 6 months;
See the full eligibility criteria
- Agree to follow the study treatment protocol and visit schedule, enroll voluntarily and sign a written informed consent;
- Male or female aged ≥ 18 years at the time of signing the ICF;
- B-cell lymphoma: ECOG performance status of 0-2;
- Advanced solid tumors: ECOG performance status of 0-1;
- Life expectancy of at least 3 months;
- Dose escalation phase: Histopathologically confirmed relapsed/refractory B-cell lymphoma following at least 2 prior lines of systemic therapy;
- Dose expansion phase: relapsed/refractory B-cell lymphoma and advanced or metastatic solid tumor of specified type.
- All people 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...
- Relapsed/refractory B-cell lymphoma: people in Phase Ia dose escalation phase should have evaluable lesions; people in Phase Ib dose expansion phase should have at least 1 radiographically measurable lymph node or...
- Advanced solid tumors: people are required to have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 ;
- people must have recovered (to ≤ Grade 1) from any AE associated with prior anticancer therapy;
- people have adequate organ and bone marrow function;
- Female people 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...
- B-cell lymphoma: known central nervous system (CNS) involvement .
- 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);
- people 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...
- people 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...
- History of severe bleeding disorders ;
- History of chronic pancreatitis or acute pancreatitis within 6 months;
- History of interstitial lung disease, radiation pneumonitis requiring steroid therapy, or any evidence of clinically active interstitial lung disease;
- Patients with uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage after intubation and drainage, VEGF inhibitors, platinum and other drugs injection (people with stable symptoms...
- Prior solid organ transplantation;
- Persistent peripheral neuropathy \> Grade 1 at baseline;
- Clinically significant cardiovascular or cerebrovascular diseases;
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection requiring systemic therapy (except for localized skin or nail bed fungal infection) at enrollment;
- Active infectious disease, such as HIV infection, active hepatitis B, active hepatitis C (positive RNA result), active syphilis;
- Receiving corticosteroids (prednisone equivalent more than 30 mg/day);
- Contraindication to any component of HDM2005;
- History of drug anaphylactic shock, severe food allergy, uncontrolled asthma/COPD;
- Female people who are pregnant, lactating or planning to become pregnant during the study;
- Known history of mental illness or substance abuse that would impair the subject's ability to cooperate with study requirements;
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
- Suzhou, Jiangsu, China
- Xuzhou, Jiangsu, China
- Nanchang, Jiangxi, China
- Jinan, Shandong, China
- Hangzhou, Zhejiang, China
- Tianjing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China; Suzhou, Jiangsu, China; Xuzhou, Jiangsu, China; Nanchang, Jiangxi, China; Jinan, Shandong, China; Hangzhou, Zhejiang, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.