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NCT Number: NCT06351527

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pan American Center for Oncology Trials, San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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 criteria

  • 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.

Treatment and study plan

ICP-248

Drug

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

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.

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.

Primary outcomes

  1. DLT

    Time frame: 49 days

    Dose-limiting toxicity (DLT) rate at each dose level DLT will be assessed via CTCAE version 5.0 or iwCLL 2018.

  2. Safety and tolerability of ICP-248 at different doses in B-cell malignancies

    Time frame: 5 years

    To investigate the incidence, nature and severity of adverse events (AE) according to NCI-CTCAE V5.0 evaluation criteria or iwCLL 2018.

Secondary outcomes

  1. Cmax, ss of ICP-248

    Time frame: Predose up to week 28

    Steady State Maximum Concentration of ICP-248

  2. Ctrough, ss of ICP-248

    Time frame: Predose up to week 28

    Steady State Trough Concentration of ICP-248

  3. Preliminary efficacy of ICP-248 monotherapy in patients with B-cell malignancy

    Time frame: 5 years

    Investigator-assessed ORR and CRR as defined by the Lugano 2014 Classification or per iwCLL 2018 criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Study Director

CONTACT

[email protected]

609-524-1106

Sponsors and collaborators

Lead sponsor

InnoCare Pharma Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2024
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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