Advanced Solid TumorsPhase 1NCT06615193
A Study of HDM2005 in Patients With Relapsed/Refractory B-cell Lymphoma and Advanced Solid Tumor
A Phase 1 study testing HDM2005 in people with Advanced Solid Tumors and Refractory Lymphoma, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Refractory Lymphoma, Relapsed Hematologic Malignancy
- What is being tested?
- HDM2005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 8 sitesChina
- Study dates
- 12 Aug 2024to 1 Feb 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- Dose expansion phase: relapsed/refractory B-cell lymphoma and advanced or metastatic solid tumor of specified type.
- 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;
- 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;
- Advanced solid tumors: subjects are required to have at least 1 measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 ;
- Subjects must have recovered (to ≤ Grade 1) from any AE associated with prior anticancer therapy;
- Subjects have adequate organ and bone marrow function;
- 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.
Who cannot join
- 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);
- 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);
- 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;
- History of severe bleeding disorders ;
- History of chronic pancreatitis or acute pancreatitis within 6 months;
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- 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 (subjects with stable symptoms for at least one week after treatment can be enrolled);
- 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 subjects 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 entirely, or is not in the subjects' best interest.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Wenjuan Yu
- Not yet recruiting
Shandong Cancer Hospital
Jinan, Shandong
Zengjun Li
Juan Li
- Not yet recruiting
The First Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi
Fei Li
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Zhengming Jin
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Bingzong Li
- Recruiting
The Institute of Hematology and Blood Diseases Hospital at the Chinese Academy of Medical Sciences
Tianjing
Lugui Qiu
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Zhenyu Li
- Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan
Keshu Zhou
About this study
Official title: 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
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.
- Being tested
- HDM2005
- Medical subject headings
- Lymphoma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HDM2005Drug
HDM2005 will be administered via IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| HDM2005 | Experimental | In dose escalation phase, participants will be administered escalating doses of HDM2005 at 0.3~2.75mg/kg IV on Day 1 of repeated 21-day cycles.
In dose expansion phase, participants will be administered to recommended dose for expansion (RDE) of HDM2005 on Day 1 of repeated 21-day cycles . Receives: Drug: HDM2005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLT) events (for dose escalation phase)
DLT will be determined by definition during the DLT observation period.
Measured: up to 21 days following first dose
Incident and severity of adverse events(for dose escalation phase)
The safety profile of HDM2005 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Measured: Until 28 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first
Objective Response Rate (ORR)(for dose expansion phase)
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator.
Measured: Until withdrawal of consent, loss to follow-up, initiation of other new antineoplastic therapy, end of study, or study termination by the sponsor, whichever occurs first (up to approximately 3.5 years)
Recommended Phase 2 Dose (RP2D) (for dose expansion phase)
The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic,E-R relationships, and efficacy data.
Measured: Approximately 3.5 years
Secondary outcomes (8)
Plasma concentration of HDM2005, total antibody and the free MMAE
Plasma concentration of HDM2005, total antibody and the free MMAE will be reported for each arm.
Measured: up to 28 days following last dose
Immunogenicity
Number and percentage of anti-drug antibody (ADA)-positive patients will be assessed.
Measured: up to 28 days following last dose
Incident and severity of adverse events(for dose expansion phase)
The safety profile of HDM2005 will be assessed by monitoring the adverse events (AE) per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.
Measured: Until 28 days after the last dose or initiation of a new antineoplastic therapy, whichever occurs first
Objective Response Rate (ORR)(for dose escalation phase)
Objective response rate (ORR), which includes best response of complete response (CR) or partial response (PR) as assessed by the investigator.
Measured: Approximately 3.5 years
Time to Response (TTR)
TTR is defined as the interval from the start of study therapy to the first documentation of an objective response.
Measured: Approximately 3.5 years
Progression free survival (PFS)
PFS is defined as the interval from the start of study therapy to the earlier of the first documentation of disease progression/relapse or death from any cause.
Measured: Approximately 3.5 years
Duration of Response (DOR)
DOR is defined as the interval from the first documentation of objective response to the earlier of the first documentation of disease progression/relapse or death from any cause.
Measured: Approximately 3.5 years
Overall survival (OS)
OS is defined as the interval from the start of study therapy to death from any cause.
Measured: Approximately 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start12 Aug 2024
- Primary completion24 Jun 2026 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615193
- Sponsor's protocol ID
- HDM2005-101
- Status last verified
- Sep 2024
- First submitted
- 19 Sep 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No