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

NCT06351527 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ICP-CL-01202
• Study Type: interventional
• Target: 78
• Locations: 3 countries
• Sites: 8

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

Conditions

Mature B-cell Malignancies

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• Cmax, ss of ICP-248

  Predose up to week 28

• Ctrough, ss of ICP-248

  Predose up to week 28

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

  5 years

Study Arms (4)

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.

Drug: ICP-248

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.

Drug: ICP-248; Drug: Obinutuzumab (G)

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.

Drug: ICP-248

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.

Drug: ICP-248; Drug: Rituximab (R)

Interventions

ICP-248 DRUG

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

Dose-Escalation Cohort - CLL/SLL and MCL; Dose-Expansion Cohort A - CLL/SLL; Dose-Expansion Cohort B - MCL; Dose-Expansion Cohort C - MCL

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.

Dose-Expansion Cohort A - CLL/SLL

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.

Dose-Expansion Cohort C - MCL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.

Sponsors & Collaborators

• InnoCare Pharma Inc.: lead

Study Sites (8)

BRCR Medical Center

Plantation, Florida, 33322, United States

RECRUITING

Clinical Research Alliance

Westbury, New York, 11590, United States

RECRUITING

Pan American Center for Oncology Trials

San Juan, 00935, Puerto Rico

RECRUITING

CNE CCOHTPC of Cherkasy Regional Council

Cherkasy, 18009, Ukraine

RECRUITING

CNE"City Clin Hosp#4"of Dnipro City Council

Dnipro, 49102, Ukraine

RECRUITING

Medical Center of Limited Liability Company Arensia Exploratory Medicine

Kyiv, 1135, Ukraine

RECRUITING

Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC

Kyiv, 2091, Ukraine

RECRUITING

SI Institute of Blood Pathology and Transfusion Medicine of AMSU

Lviv, 79057, Ukraine

RECRUITING

MeSH Terms

Interventions

obinutuzumab; Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Study Director

CONTACT

609-524-1106; ICP-CL-1202general@innocarepharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 8, 2024
• Study Start: April 23, 2024
• Primary Completion (Estimated): June 25, 2027
• Study Completion (Estimated): October 25, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

PR (1); UA (5); US (2)