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

NCT ID: NCT06615193

Last Updated: 2024-09-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-12
• Study Completion Date: 2028-02-01

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.

Conditions

Advanced Solid Tumors; Refractory Lymphoma; Relapsed Hematologic Malignancy

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HDM2005

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 .

Group Type: EXPERIMENTAL

HDM2005

Intervention Type: DRUG

HDM2005 will be administered via IV infusion.

Interventions

HDM2005

HDM2005 will be administered via IV infusion.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status: NOT_YET_RECRUITING

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status: RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status: RECRUITING

The First Affiliated Hospital Of Nanchang University

Nanchang, Jiangxi, China

Site Status: NOT_YET_RECRUITING

Shandong Cancer Hospital

Jinan, Shandong, China

Site Status: NOT_YET_RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: NOT_YET_RECRUITING

The Institute of Hematology and Blood Diseases Hospital at the Chinese Academy of Medical Sciences

Tianjing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Zhou, Master

Role: CONTACT

hdgdzhoujun@eastchinapharm.com

18061872796

Facility Contacts

Keshu Zhou

Role: primary

Zhengming Jin

Role: primary

Bingzong Li

Role: primary

Zhenyu Li

Role: primary

Fei Li

Role: primary

Zengjun Li

Role: primary

Juan Li

Role: backup

Wenjuan Yu

Role: primary

Lugui Qiu

Role: primary

Other Identifiers

HDM2005-101

Identifier Type: -

Identifier Source: org_study_id