A Study of KPG-818 in Hematological Malignancies (Blood & Immune System Cancers)
This is a phase 1, multicenter, open-label, multiple-ascending dose study to evaluate the safety, pharmacokinetics and clinical activity of KPG-818 in subjects with hematological malignancies. Approximately 30 patients will be enrolled for dose escalation of 4 dose levels.
Indication: Hematological malignancies (multiple myeloma [MM], mantle cell lymphoma [MCL], diffuse large B-cell lymphoma [DLBCL], adult T-cell leukemia-lymphoma [ATL], and indolent non Hodgkin lymphomas such as follicular lymphoma [FL] and chronic lymphocytic leukemia [CLL]/small lymphocytic lymphoma [SLL]).
A Phase 1, Multicenter, Open-label, Multiple-ascending Dose Study to Evaluate the Safety, Pharmacokinetics and Clinical Activity of KPG-818 in Subjects With Hematological Malignancies
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.
Hematological Malignancies, Neoplasms, Hematologic Neoplasms, KPG-818
You can join if…
Open to people ages 18 years and up
- ≥ 18 years of age
- Willing and able to provide written consent.
- Willing and able to adhere to the study visit schedule and other protocol requirements.
- Hematocytological or pathological diagnosis of MM, MCL, DLBCL, ATL, indolent lymphoma, such as FL and CLL/SLL, etc.
- Subjects who have relapsed from or are refractory to MM, MCL, DLBCL, ATL, indolent lymphoma, such as FL and CLL/SLL.
- Have measurable or assessable disease.
- Meet the laboratory requirements:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Males and females of childbearing potential must agree to use at least two methods of contraception and continue until 3 months after the completion of study treatment.
You CAN'T join if...
- Has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
- Currently enrolled in another clinical study, except observational studies.
- Has known active central nervous system metastases and/or lymphomatous meningitis.
- Persisting toxicities related to prior anticancer treatment > Grade 1.
- Major surgery or significant traumatic injury within 6 weeks prior to Screening or planned major surgery during the study period.
- Received live attenuated vaccine within 4 weeks of first dose.
- Subjects with gastrointestinal disease that may significantly alter the absorption of the study drug.
- Subjects with a plasma cell leukemia.
Subjects with prior history of malignancies, other than MM, lymphoma, or CLL/SLL, unless the subject has been free of the disease for ≥ 5 years.
10. Has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or
11. Has known or suspected hypersensitivity to the excipients contained in the formulation
of investigational product (IP).
12. Has been treated with an investigational agent (i.e., an agent not commercially
available) within 28 days of initiating IP.
13. Prior treatment of any inhibitors of PD-1 or PD-L1 within 3 months prior to initiating
14. Has any one of the following:
- Clinically significant abnormal ECG finding at Screening.
- Congestive heart failure.
- Myocardial infarction within 12 months prior to initiating IP.
- Unstable or poorly controlled angina pectoris, including the Prinzmetal variant of angina pectoris.
- Peripheral neuropathy ≥ Grade 2.
- Subject has taken a strong inhibitor or inducer of CYP3A4/5 including grapefruit, St. John's Wort or related products within 2 weeks prior to dosing and during the course of study.
- Has current or prior use of immunosuppressive medication within 14 days prior initiating IP.
- UC Davis Comprehensive Cancer Center
accepting new patients
Sacramento California 95817 United States
- Providence Portland Medical Center
Portland Oregon 97213 United States
- accepting new patients
- Start Date
- Completion Date
- Kangpu Biopharmaceuticals, Ltd.
- Phase 1 research study
- Study Type
- Expecting 30 study participants
- Last Updated
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