RecruitingPhase 1NCT06615193

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


Sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Enrollment

111 participants

Start Date

Aug 12, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new drug called HDM2005 in people with relapsed or refractory B-cell lymphoma (a blood cancer) or advanced solid tumors that have not responded to standard treatments. The study first evaluates safety and dosing, then expands to look at effectiveness. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with B-cell lymphoma (ECOG 0–2) or advanced solid tumors (ECOG 0–1) that have relapsed or progressed after standard treatments - Your expected survival is at least 3 months - You have adequate organ function and blood counts **You may NOT be eligible if...** - You have had recent stem cell transplantation or CAR-T therapy - You have active brain metastases that are untreated - You have serious autoimmune conditions or are on immune-suppressing drugs - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGHDM2005

HDM2005 will be administered via IV infusion.


Locations(8)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06615193


Related Trials