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
NCT ID: NCT06351527
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
78 participants
INTERVENTIONAL
2024-04-23
2027-10-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dose-Escalation Cohort - CLL/SLL and MCL
Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose. Cycles will comprise 28 days.
ICP-248
ICP-248 will be administered orally once daily at escalated doses (starting dose 5/10 mg, maximum 150 mg).
Dose-Expansion Cohort A - CLL/SLL
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.
ICP-248
ICP-248 will be administered orally once daily at escalated doses (starting dose 5/10 mg, maximum 150 mg).
Obinutuzumab (G)
Obinutuzumab will be administered by IV infusion at a dose of 100 mg or 1000 mg, depending on splitting rules, at Cycle 1, Day 1 (if 100 mg was received on Day 1, 900 mg will be administered on Cycle 1, Day 2); 1000 mg at Cycle 1, Day 8 and Day 15; 1000 mg at Day 1 for all subsequent cycles until the end of Cycle 6.
Dose-Expansion Cohort B - MCL
Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose. Cycles will comprise 28 days.
ICP-248
ICP-248 will be administered orally once daily at escalated doses (starting dose 5/10 mg, maximum 150 mg).
Dose-Expansion Cohort C - MCL
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.
ICP-248
ICP-248 will be administered orally once daily at escalated doses (starting dose 5/10 mg, maximum 150 mg).
Rituximab (R)
Rituximab will be administered by IV infusion at a dose of 375 milligrams per square meter (mg/m\^2) at Day 1 per week for 4 weeks during cycle 1, then on day 1 of cycles 3-8, and thereafter once every other cycle up to 2 years.
Interventions
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ICP-248
ICP-248 will be administered orally once daily at escalated doses (starting dose 5/10 mg, maximum 150 mg).
Obinutuzumab (G)
Obinutuzumab will be administered by IV infusion at a dose of 100 mg or 1000 mg, depending on splitting rules, at Cycle 1, Day 1 (if 100 mg was received on Day 1, 900 mg will be administered on Cycle 1, Day 2); 1000 mg at Cycle 1, Day 8 and Day 15; 1000 mg at Day 1 for all subsequent cycles until the end of Cycle 6.
Rituximab (R)
Rituximab will be administered by IV infusion at a dose of 375 milligrams per square meter (mg/m\^2) at Day 1 per week for 4 weeks during cycle 1, then on day 1 of cycles 3-8, and thereafter once every other cycle up to 2 years.
Eligibility Criteria
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Exclusion Criteria
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 anti-infective 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. Grade 2 or above toxicity due to prior anti-cancer therapy at screening
11. Known alcohol or drug dependence
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.
18 Years
ALL
No
Sponsors
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InnoCare Pharma Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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BRCR Medical Center
Role: primary
Clinical Research Alliance
Role: primary
Pan American Center for Oncology Trials
Role: primary
CNE CCOHTPC of Cherkasy Regional Council
Role: primary
CNE CCOHTPC of Cherkasy Regional Council
Role: primary
Medical Center of Limited Liability Company Arensia Explorator
Role: primary
Med Center 'Ok!Clinic+' of International Institute of Clinical
Role: primary
SI Institute of Blood Pathology and Transfusion Medicine of AM
Role: primary
Other Identifiers
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ICP-CL-01202
Identifier Type: -
Identifier Source: org_study_id
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