Clinical trial NCT06351527: Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 in Patients With Mature B-cell Malignancies
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Mature B-cell Malignancies
Lead sponsor: InnoCare Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ICP-248 in Mature B-cell Malignancies


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.

Primary outcomes:
measure: Maximum tolerated dose and/or recommended Phase 2 dose
timeFrame: 5 years
measure: To investigate the incidence, nature and severity of adverse events (AE) according to NCI-CTCAE V5.0 evaluation criteria.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: