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Trial Title:
Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies
NCT ID:
NCT06351527
Condition:
Mature B-cell Malignancies
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ICP-248
Description:
Eligible patients will receive ICP-248 orally as per the protocol
Arm group label:
ICP-248
Summary:
Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ICP-248
in Mature B-cell Malignancies
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥ 18 and ≤ 80 years.
2. Subjects with histopathologically and/or flow cytometry-confirmed diseases according
to the 2016 World Health Organization (WHO) classification criteria for
lymphohematopoietic neoplasms or meeting the International Workshop on Chronic
Lymphocytic Leukemia (iwCLL) criteria
3. Relapsed disease
4. For subjects with R/R MCL: Patients must have measurable disease
5. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS)
score of ≤ 1 and a life expectancy of ≥ 6 months.
6. Adequate hematologic function
7. Patients with basically normal coagulation function
8. Patients with adequate hepatic, renal, pulmonary and cardiac functions
9. Subjects are able to communicate with the investigator well and to complete the
study as specified in the study.
Exclusion Criteria:
1. Known central nervous system involvement by lymphoma/leukemia.
2. Known or suspected history of Richter's transformation.
3. Prior autologous stem cell transplant (unless ≥ 3 months since transplant); or prior
chimeric cell therapy (unless ≥ 3 months since cell infusion).
4. A history of allogeneic stem cell transplantation.
5. An interval of less than 5 half-lives from the last dose of a strong CYP3A or CYP2C8
inhibitor or inducer (chemical agent, herbal medicine and dietary supplement) to the
first dose of the investigational product, or a plan to use concurrently
medications, dietary supplements or food (e.g., grapefruit or grapefruit juice) with
strong CYP3A or CYP2C8 inhibitory or inductive effect during study participation
6. Presence of active infection that currently requires intravenous systemic
antiinfective therapy.
7. History of immunodeficiency, including a positive human immunodeficiency virus (HIV)
antibody test.
8. History of significant cardiovascular disease
9. Patients with previous or concomitant central nervous system disorders
10. Known alcohol or drug dependence
11. Female patients who are pregnant or lactating.
12. Unable to swallow tablets or presence of disease significantly affecting
gastrointestinal function such as malabsorption syndrome, resection of the stomach
or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel
disease, or partial or complete bowel obstruction.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
April 25, 2024
Completion date:
October 25, 2027
Lead sponsor:
Agency:
InnoCare Pharma Inc.
Agency class:
Industry
Source:
InnoCare Pharma Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06351527
