BN104 in Combination With Chemotherapy or Targeted Agents for Acute Myeloid Leukemia
- Sponsor
- Chen Suning
- Study ID
- NCT06746519
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine — DRUGThe starting dose cohort(200mg BID N104) combined Intensive Chemotherapyor Venetoclax/Azacitidine. Each treatment cycle is anticipated to be 28 days in length, although cycle delays may be made due to delayed count recovery.
Study Details
The Phase I/II trial is to learn the safety, pharmacokinetics, and preliminary efficacy of BN104 taken twice daily combined with Intensive Chemotherapy or Venetoclax/Azacitidine in patients with acute myeloblastic leukemia.
Key Dates
- Start date
- Dec 25, 2024
- Status verified
- Dec 2024
- Primary completion
- Dec 30, 2025
- Completion
- Jun 30, 2027
Study Design
- Enrollment
- 135 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: BN104 Combined Intensive Chemotherapy in patients with newly diagnosed AML
- Experimental: BN104 Combined Venetoclax/Azacitidine in patients with newly diagnosed AML
- Experimental: BN104 Combined Venetoclax/Azacitidine in patients with relapsed/refractory AML
Primary Outcome Measure
Evaluate the safety and tolerability of BN104 in combination with Venetoclax/Azacitidine or intensive chemotherapy [ Time Frame: At the end of Cycle1 (Cycle1 Day28) ]
Central Contacts
- Suning Chen, Doctor051265223637
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