RecruitingPhase 1Phase 2NCT05719701

Evaluate the Safety, Tolerability, and Efficacy of ICP-490 in Patients With Relapsed and/or Refractory Multiple Myeloma

A Multi-center, Non-randomized, and Open-label Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of ICP-490 in Patients With Relapsed and/or Refractory Multiple Myeloma


Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Enrollment

80 participants

Start Date

Mar 29, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multi-center, non-randomized and open-label phase I/IIa clinical study to evaluate the safety, tolerability, and efficacy of ICP-490 in patients with relapsed and/or refractory multiple myeloma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called ICP-490 for patients with multiple myeloma (a blood cancer affecting plasma cells in the bone marrow) that has come back or stopped responding to previous treatments. This is an early-phase trial assessing how safe the drug is and whether it works. **You may be eligible if...** - You are 18 or older with confirmed relapsed or refractory multiple myeloma - Your cancer is measurable on standard tests - You are in reasonably good health (ECOG score 0-2) - Your organ function (liver, kidneys, blood counts) is adequate - Your expected survival is at least 6 months **You may NOT be eligible if...** - You have multiple myeloma that has spread to the central nervous system - You have a type of plasma cell disease other than typical myeloma (e.g., plasma cell leukemia, POEMS syndrome, or amyloidosis) - You have had another active cancer within the past 5 years (except locally cured cancers) - You have significant heart disease or an active infection - You had major surgery within 28 days before starting treatment 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

DRUGICP-490

Several dose groups of ICP-490 are planned for the dose exploration.

DRUGDexamethasone

Oral Dexamethasone is administered on Days 1, 8, 15, and 22 of each 28-day cycle.


Locations(6)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Henan Cancer Hosptital

Zhengzhou, Henan, China

Peking University People's Hospital

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT05719701


Related Trials