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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Aged ≥ 18 years old.

• Diagnosed as relapsed and/or refractory multiple myeloma .The patient must have measurable diseases.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.

• Patients must have adequate organ function. Expected survival time ≥ 6 months.

• All toxicities caused by prior anticancer therapy must have recovered to Grade ≤ 1 (based on CTCAE v5.0) except alopecia and fatigue.

⁃ Female patients of childbearing potential should have a negative blood pregnancy test result within 48 h prior to the first dose of investigational drug.

Locations
Other Locations
China
Peking University People's Hospital
RECRUITING
Beijing
Sun Yat-sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
The First Affiliated Hospital,Zhejiang University School of Medicine
NOT_YET_RECRUITING
Hangzhou
Renji Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Henan Cancer Hosptital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
April Huang
April.huang@innocarepharma.com
010-66609723
Time Frame
Start Date: 2023-03-29
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 80
Treatments
Experimental: ICP-490
Experimental: ICP-490 in combination with Dexamethasone
Related Therapeutic Areas
Sponsors
Leads: Beijing InnoCare Pharma Tech Co., Ltd.

This content was sourced from clinicaltrials.gov