KPG-818
Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects
What will happen during the trial?
This will be a dose escalation study in subjects with selected hematological malignancies. KPG-818 will be used in combination with dexamethasone in subjects with MM, and as monotherapy for other selected hematological malignancies. Each dose of KPG-818 will be administered orally until the completion of treatment cycles, or progressive disease (PD), unacceptable toxicity, the subject withdraws, or any other study withdrawal criterion is met.
The highest dose level which may be tested is 5 mg KPG-818 and dose levels 2, 3, 4, and 5 mg and/or intermediate dosing or alternative dosing schedule may be explored. Each dose level (1-4) will be tested using the standard 3+3 design. DLT will be assessed during the DLT evaluation period (Cycle 1) and the treatment of study is divided into 6 cycles.
More Information
- Trial Status
- Accepting patients
- Trial Phase
- Phase 1
- Enrollment
- 56 patients (estimated)
- Sponsors
- Kangpu Biopharmaceuticals, Ltd.
- Tags
- Cereblon E3 Ligase Modulators (CELMoDs)
- Trial Type
- Treatment
- Last Update
- 2 weeks ago
- SparkCures ID
- 1076
- NCT Identifier
- NCT04283097
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