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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose-Escalation Cohort - CLL/SLL and MCL | Experimental | Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose. Cycles will comprise 28 days. |
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| Dose-Expansion Cohort A - CLL/SLL | Experimental | 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. |
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| Dose-Expansion Cohort B - MCL | Experimental | Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose. Cycles will comprise 28 days. |
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| Dose-Expansion Cohort C - MCL | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-248 | Drug | ICP-248 will be administered orally once daily at escalated doses (starting dose 5/10 mg, maximum 150 mg). |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT | Dose-limiting toxicity (DLT) rate at each dose level DLT will be assessed via CTCAE version 5.0 or iwCLL 2018. | 49 days |
| Safety and tolerability of ICP-248 at different doses in B-cell malignancies | To investigate the incidence, nature and severity of adverse events (AE) according to NCI-CTCAE V5.0 evaluation criteria or iwCLL 2018. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax, ss of ICP-248 | Steady State Maximum Concentration of ICP-248 | Predose up to week 28 |
| Ctrough, ss of ICP-248 | Steady State Trough Concentration of ICP-248 |
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Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Contact | 609-524-1106 | ICP-CL-1202general@innocarepharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BRCR Medical Center | Recruiting | Plantation | Florida | 33322 | United States |
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| Obinutuzumab (G) | Drug | 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. |
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| Rituximab (R) | Drug | 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. |
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| Predose up to week 28 |
| Preliminary efficacy of ICP-248 monotherapy in patients with B-cell malignancy | Investigator-assessed ORR and CRR as defined by the Lugano 2014 Classification or per iwCLL 2018 criteria | 5 years |
| Clinical Research Alliance | Recruiting | Westbury | New York | 11590 | United States |
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| Pan American Center for Oncology Trials | Recruiting | San Juan | 00935 | Puerto Rico |
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| CNE CCOHTPC of Cherkasy Regional Council | Recruiting | Cherkasy | 18009 | Ukraine |
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| CNE"City Clin Hosp#4"of Dnipro City Council | Recruiting | Dnipro | 49102 | Ukraine |
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| Medical Center of Limited Liability Company Arensia Exploratory Medicine | Recruiting | Kyiv | 1135 | Ukraine |
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| Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC | Recruiting | Kyiv | 2091 | Ukraine |
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| SI Institute of Blood Pathology and Transfusion Medicine of AMSU | Recruiting | Lviv | 79057 | Ukraine |
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| ID | Term |
|---|---|
| C543332 | obinutuzumab |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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