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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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 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.

Locations
Other Locations
China
The First Affiliated Hospital of Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Shandong Cancer Hospital
NOT_YET_RECRUITING
Jinan
The First Affiliated Hospital Of Nanchang University
NOT_YET_RECRUITING
Nanchang
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
The Second Affiliated Hospital of Soochow University
RECRUITING
Suzhou
The Institute of Hematology and Blood Diseases Hospital at the Chinese Academy of Medical Sciences
RECRUITING
Tianjing
The Affiliated Hospital of Xuzhou Medical University
RECRUITING
Xuzhou
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Jun Zhou, Master
hdgdzhoujun@eastchinapharm.com
18061872796
Time Frame
Start Date: 2024-08-12
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 111
Treatments
Experimental: 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 .
Related Therapeutic Areas
Sponsors
Leads: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov