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A Single-Arm, Multicenter, Open-Label, Dose- Escalating and Expanding,Phase I/II Study of SKLB1028 Combined With "7+3" Standard Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jul 28, 2026
Report code
NCT05445154-Jul 28, 2026
NCT ID
NCT05445154
Status
RECRUITING
Phase
Phase 1/2
Sponsor
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Executive brief
Investment-Ready Snapshot
SKLB1028, developed by CSPC ZhongQi Pharmaceutical Technology Co., Ltd., is currently undergoing a Phase I/II clinical trial to evaluate its safety, tolerability, and pharmacokinetics when combined with the standard '7+3' chemotherapy regimen in patients with newly diagnosed AML. The trial is particularly focused on patients with FLT3 mutations, a significant subset of AML that represents a substantial market opportunity due to the high unmet need for effective therapies. The competitive landscape includes other FLT3 inhibitors such as midostaurin and gilteritinib, which have established their efficacy in this patient population. Successful outcomes from this trial could position SKLB1028 as a viable treatment option, potentially enhancing CSPC's portfolio in the oncology space and providing a strategic advantage in the growing AML market.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT05445154
Indication
Newly Diagnosed Acute Myeloid Leukemia (AML)
Modality
small molecule
Target
FLT3 mutations in acute myeloid leukemia (AML)
Intervention
SKLB1028 Dose Escalation
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.