Trial Title:
Evaluate the Safety, Tolerability, and Efficacy of ICP-490 in Patients With Relapsed and/or Refractory Multiple Myeloma
NCT ID:
NCT05719701
Condition:
Relapsed and/or Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ICP-490
Description:
Several dose groups of ICP-490 are planned for the dose exploration.
Arm group label:
ICP-490
Arm group label:
ICP-490 in combination with Dexamethasone
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Oral Dexamethasone is administered on Days 1, 8, 15, and 22 of each 28-day cycle.
Arm group label:
ICP-490 in combination with Dexamethasone
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged ≥ 18 years old.
2. 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.
3. Patients must have adequate organ function. Expected survival time ≥ 6 months.
4. 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.
Exclusion Criteria:
1. Known active central nervous system (CNS) involvement or history of the disease, or
clinical signs of multiple myeloma meningeal/spinal meningeal involvement.
2. Patients with solitary plasmacytoma; plasma cell leukemia (PCL) (active PCL or
history of PCL); Waldenström's macroglobulinemia; POEMS syndrome or symptomatic
amyloidosis.
3. Prior active or history of malignancies other than MM, occurring within 5 years
prior to the first dose of investigational drug, with the exception of radically
treated local curable cancers.
4. Uncontrolled or severe cardiovascular disorders.
5. Any active infection within 14 days prior to the first dose of investigational drug.
6. Patients with diseases restricted from participation as described in the protocol
7. Having undergone major surgery within 28 days prior to the first dose of
investigational drug, or minor surgery within 2 weeks prior to the first dose. Any
severe or uncontrolled systemic disease evaluated by investigatorthat may increase
the risk associated with study participation and drug administration or affect the
patient's ability to receive the investigational drug.
8. Patients who have received any other systemic treatment, anti-tumor traditional
Chinese (herbal) medicine therapy , and any other investigational drug therapy for
MM within 28 days or 5 half-lives of the drugs (whichever is shorter) prior to the
first dose of investigational drug.
9. Patients who have received systemic treatment with corticosteroids or other
immunosuppressive drugs within 14 days prior to the first dose of investigational
drug.
Subjects are allowed to use topical, ocular, intra-articular, intranasal, and
inhaledcorticosteroid ; short-term use (≤ 7 days) of corticosteroid for prophylaxis
(e.g., contrast agent allergy) or for the treatment of non-autoimmune diseases
(e.g., delayed hypersensitivity reaction caused by contact allergens) is permitted.
10. Patients who have received medications or foods with strong inhibitory or inductive
effects on cytochrome P450 CYP3A, and proton pump inhibitorswithin 2 weeks prior to
the first dose of investigational drug, or are planning to receive them during the
study.
11. Patients with a history of severe allergic reactions to IMIDs , or dexamethasone, or
to any component contained in ICP-490 or dexamethasone formulation (CTCAE V5.0 Grade
> 3).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaojun Huang, PhD
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510120
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yang Liang
Facility:
Name:
Henan Cancer Hosptital
Address:
City:
Zhengzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Baijun Fang
Facility:
Name:
Shengjing Hospital of China Medical University
Address:
City:
Shenyang
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Aijun Liao, PhD
Facility:
Name:
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Lijing Shen
Facility:
Name:
The First Affiliated Hospital，Zhejiang University School of Medicine
Address:
City:
Hangzhou
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Zhen Cai, PhD
Start date:
March 29, 2023
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Beijing InnoCare Pharma Tech Co., Ltd.
Agency class:
Industry
Source:
Beijing InnoCare Pharma Tech Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05719701
