Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination With Anti-CD20 Monoclonal Antibody in Mature B-cell Malignancies
- Conditions
- Mature B-cell Malignancies
- Interventions
- Registration Number
- NCT06351527
- Lead Sponsor
- InnoCare Pharma Inc.
- Brief Summary
Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ICP-248 as monotherapy or in combination with anti-CD20 monoclonal antibody in Mature B-cell Malignancies
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 78
Not provided
- Known central nervous system involvement by lymphoma/leukemia.
- Known or suspected history of Richter's transformation.
- Prior autologous stem cell transplant (unless ≥ 3 months since transplant); or prior chimeric cell therapy (unless ≥ 3 months since cell infusion).
- A history of allogeneic stem cell transplantation.
- 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
- Presence of active infection that currently requires intravenous systemic anti-infective therapy.
- History of immunodeficiency, including a positive human immunodeficiency virus (HIV) antibody test.
- History of significant cardiovascular disease
- Patients with previous or concomitant central nervous system disorders
- Grade 2 or above toxicity due to prior anti-cancer therapy at screening
- Known alcohol or drug dependence
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Dose-Expansion Cohort C - MCL Rituximab (R) Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose and Rituximab for 18 cycles. Cycles will comprise 28 days. Dose-Escalation Cohort - CLL/SLL and MCL ICP-248 Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose. Cycles will comprise 28 days. Dose-Expansion Cohort A - CLL/SLL ICP-248 Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose and obinutuzumab for 6 cycles. Cycles will comprise 28 days. Dose-Expansion Cohort A - CLL/SLL Obinutuzumab (G) Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose and obinutuzumab for 6 cycles. Cycles will comprise 28 days. Dose-Expansion Cohort B - MCL ICP-248 Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose. Cycles will comprise 28 days. Dose-Expansion Cohort C - MCL ICP-248 Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose and Rituximab for 18 cycles. Cycles will comprise 28 days.
- Primary Outcome Measures
Name Time Method Safety and tolerability of ICP-248 at different doses in B-cell malignancies 5 years To investigate the incidence, nature and severity of adverse events (AE) according to NCI-CTCAE V5.0 evaluation criteria or iwCLL 2018.
DLT 49 days Dose-limiting toxicity (DLT) rate at each dose level DLT will be assessed via CTCAE version 5.0 or iwCLL 2018.
- Secondary Outcome Measures
Name Time Method Cmax, ss of ICP-248 Predose up to week 28 Steady State Maximum Concentration of ICP-248
Preliminary efficacy of ICP-248 monotherapy in patients with B-cell malignancy 5 years Investigator-assessed ORR and CRR as defined by the Lugano 2014 Classification or per iwCLL 2018 criteria
Ctrough, ss of ICP-248 Predose up to week 28 Steady State Trough Concentration of ICP-248
Trial Locations
- Locations (8)
BRCR Medical Center
🇺🇸Plantation, Florida, United States
Clinical Research Alliance
🇺🇸Westbury, New York, United States
Pan American Center for Oncology Trials
🇵🇷San Juan, Puerto Rico
CNE CCOHTPC of Cherkasy Regional Council
🇺🇦Cherkasy, Ukraine
CNE"City Clin Hosp#4"of Dnipro City Council
🇺🇦Dnipro, Ukraine
Medical Center of Limited Liability Company Arensia Exploratory Medicine
🇺🇦Kyiv, Ukraine
Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
🇺🇦Kyiv, Ukraine
SI Institute of Blood Pathology and Transfusion Medicine of AMSU
🇺🇦Lviv, Ukraine
BRCR Medical Center🇺🇸Plantation, Florida, United StatesBRCR Medical CenterContact