The Study of ICP-248 in Patients With Mature B-cell Malignancies

Sponsor
Beijing InnoCare Pharma Tech Co., Ltd.
Study ID
NCT05728658
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Hematological Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • ICP-248 — DRUG
    Eligible patients will receive ICP-248 orally as per the protocol, once daily for every 28 days as one treatment cycle (except for the food effect investigation phase), until progressive disease (PD), intolerable toxicity, withdrawal of consent, loss to follow-up, initiation of other anti-cancer therapy, death, or end of study, whichever occurs first.
  • ICP-248 — DRUG
    Eligible patients will receive ICP-248 orally as specified in the treatment arm.
  • ICP-248+Orelabrutinib — DRUG
    Eligible patients will receive ICP-248 and Orelabrutinib as specified in the treatment arm.
  • ICP-248+Orelabrutinib — DRUG
    Eligible patients will receive ICP-248 and Orelabrutinib as specified in the treatment arm.
  • ICP-248 +Rituximab — DRUG
    Eligible patients will receive ICP-248 and Rituximab as specified in the treatment arm.
  • ICP-248+Orelabrutinib — DRUG
    Eligible patients will receive ICP-248 and Orelabrutinib as specified in the treatment arm.
  • ICP-248+Orelabrutinib+Rituximab — DRUG
    Eligible patients will receive ICP-248 and Orelabrutinib and Rituximab as specified in the treatment arm.

Study Details

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ICP-248 as Monotherapy or in Combination Therapy in Patients with Mature B-cell Malignancies.This study consists of two parts: Part 1 dose-finding period and Part 2 dose expansion period.

Key Dates

Start date
Mar 9, 2023
Status verified
Sep 2025
Primary completion
Aug 30, 2025
Completion
Oct 30, 2026

Study Design

Enrollment
191 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose-Escalation Cohort - R/R CLL/SLL and R/R MCL
    ICP-248 was divided into 6 dose groups, and each dose group was given progressively
  • Experimental: Dose-Expansion Cohort A/B/C/D/E/F (R/R CLL/SLL、R/R MCL、R/R B-NHL)
    Participants will receive ICP-248 daily with a weekly ramp-up schedule from Cycle 1 day 1.
  • Experimental: Dose-Expansion Cohort G(R/R MCL)
    Participants will receive ICP-248 daily with a ramp-up phase, and will receive Orelabrutinib 150 mg daily, until progressive disease (PD),intolerable toxicity,withdrawal of consent, loss to follow-up, initiation of other anti-cancer therapy, death,or end of study,whichever occurs first.
  • Experimental: Dose-Expansion Cohort H(R/R MZL)
    Participants will receive ICP-248 daily with a weekly ramp-up schedule and Orelabrutinib 150 mg daily from Cycle 1 day 1, until progressive disease (PD),intolerable toxicity,withdrawal of consent, loss to follow-up, initiation of other anti-cancer therapy, death,or end of study,whichever occurs first.
  • Experimental: Dose-Expansion Cohort I(R/R CLL/SLL)
    Participants will receive ICP-248 daily with a weekly ramp-up schedule from Cycle 1 day 1, and will receive 375 mg/m2 Rituximab on day 1 of each cycle from C1 to C6,or until progressive disease (PD),intolerable toxicity,withdrawal of consent, loss to follow-up, initiation of other anti-cancer therapy, death,or end of study,whichever occurs first.
  • Experimental: Dose-Expansion Cohort J(R/R CLL/SLL)
    Participants will receive Orelabrutinib 150 mg daily from cycle 1 day 1, and will receive ICP-248 daily with a daily ramp-up schedule from Cycle 3 day 1, until progressive disease (PD),intolerable toxicity,withdrawal of consent, loss to follow-up, initiation of other anti-cancer therapy, death,or end of study,whichever occurs first.
  • Experimental: Dose-Expansion Cohort K(MCL)
    Participants will receive Orelabrutinib 150 mg daily from cycle 1 day 1, and Rituximab 375 mg per square meter was infused intravenously on day 1 of each cycle from C1-6 and on day 1 of every two cycles from C7D1 onwards, and ICP-248 daily with a weekly ramp-up schedule from cycle 3 day 1. The treatment will continue up to a maximum of 24 cycles, or until progressive disease (PD),intolerable toxicity,withdrawal of consent, loss to follow-up, initiation of other anti-cancer therapy, death,or end of study,whichever occurs first.

Primary Outcome Measure

Maximum tolerated dose and recommended Phase 2 dose [ Time Frame: 5 years ]

Central Contacts

Related Studies