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

First listed

Apr 8, 2024

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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