Mature B-cell MalignanciesPhase 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 1 study testing ICP-248, Obinutuzumab (G) and Rituximab (R) in people with Mature B-cell Malignancies, run by InnoCare Pharma Inc. at 8 sites in 3 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mature B-cell Malignancies
- What is being tested?
- ICP-248, Obinutuzumab (G) and Rituximab (R)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 23 Apr 2024to 25 Oct 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 3 countries
Ukraine5 sites, 5 recruiting
- Recruiting
CNE CCOHTPC of Cherkasy Regional Council
Cherkasy, 18009
CNE CCOHTPC of Cherkasy Regional Council
- Recruiting
CNE"City Clin Hosp#4"of Dnipro City Council
Dnipro, 49102
CNE CCOHTPC of Cherkasy Regional Council
- Recruiting
Medical Center of Limited Liability Company Arensia Exploratory Medicine
Kyiv, 1135
Medical Center of Limited Liability Company Arensia Explorator
- Recruiting
Med Center 'Ok!Clinic+' of International Institute of Clinical Trials LLC
Kyiv, 2091
Med Center 'Ok!Clinic+' of International Institute of Clinical
- Recruiting
SI Institute of Blood Pathology and Transfusion Medicine of AMSU
Lviv, 79057
SI Institute of Blood Pathology and Transfusion Medicine of AM
United States2 sites, 2 recruiting
- Recruiting
BRCR Medical Center
Plantation, Florida, 33322
BRCR Medical Center
- Recruiting
Clinical Research Alliance
Westbury, New York, 11590
Clinical Research Alliance
Puerto Rico1 site, 1 recruiting
- Recruiting
Pan American Center for Oncology Trials
San Juan, 00935
Pan American Center for Oncology Trials
About this study
Official 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
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
- Being tested
- ICP-248, Obinutuzumab (G), Rituximab (R)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-248Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: ICP-248; Drug: Rituximab (R) |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose-limiting toxicity (DLT) rate at each dose level DLT will be assessed via CTCAE version 5.0 or iwCLL 2018.
Measured: 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.
Measured: 5 years
Secondary outcomes (3)
Cmax, ss of ICP-248
Steady State Maximum Concentration of ICP-248
Measured: Predose up to week 28
Ctrough, ss of ICP-248
Steady State Trough Concentration of ICP-248
Measured: 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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start23 Apr 2024
- Primary completion25 Jun 2027 (estimated)
- Study completion25 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mature B-cell MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- InnoCare Pharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351527
- Sponsor's protocol ID
- ICP-CL-01202
- Status last verified
- Jun 2025
- First submitted
- 2 Apr 2024
- Last updated
- 19 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No