RecruitingPhase 1NCT06351527

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

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination With Anti-CD20 Monoclonal Antibody in Patients With Mature B-cell Malignancies


Sponsor

InnoCare Pharma Inc.

Enrollment

78 participants

Start Date

Apr 23, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Inclusion Criteria8

  • Age ≥ 18.
  • 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: relapsed or refractory CLL/SLL, relapsed or refractory MCL. Patients must have received at least two prior lines of adequate systemic therapy before study entry, and at least one prior systemic therapy should include Bruton's kinase inhibitor (BTKi).
  • For subjects with R/R MCL: Patients must have measurable disease per the Lugano 2014 criteria.
  • Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of ≤ 1 and a life expectancy of ≥ 6 months.
  • Adequate hematologic, hepatic, renal, pulmonary and cardiac function
  • Patients with basically normal coagulation function
  • Patients with fertility potential and their partners need contraception
  • Subjects can communicate with the investigator well and to complete the study as specified in the study.

Exclusion Criteria12

  • 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.

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Interventions

DRUGICP-248

ICP-248 will be administered orally once daily at escalated doses (starting dose 5/10 mg, maximum 150 mg).

DRUGObinutuzumab (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.

DRUGRituximab (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.


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

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NCT06351527