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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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

Key Dates

Start date

Apr 23, 2024

Status verified

Jun 2025

Primary completion

Jun 25, 2027

Completion

Oct 25, 2027

Study Design

Enrollment

78 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Dose-Escalation Cohort - CLL/SLL and MCL
  Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose. Cycles will comprise 28 days.
• Experimental: Dose-Expansion Cohort A - CLL/SLL
  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.
• Experimental: Dose-Expansion Cohort B - MCL
  Participants will receive ICP-248 daily from an initial dose of 5/10 mg to the target dose. Cycles will comprise 28 days.
• Experimental: Dose-Expansion Cohort C - MCL
  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.

Primary Outcome Measure

DLT [ Time Frame: 49 days ]

Central Contacts

• Study Director
  609-524-1106
  [email protected]

Locations (2)

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