Status:
COMPLETED
Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects
Lead Sponsor:
Kangpu Biopharmaceuticals, Ltd.
Conditions:
Hematological Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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. Approxi...
Detailed Description
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 sele...
Eligibility Criteria
Inclusion
- ≥ 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.
Exclusion
- 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.
- Has a history of anaphylaxis or hypersensitivity to thalidomide, lenalidomide, or pomalidomide.
- Has known or suspected hypersensitivity to the excipients contained in the formulation of investigational product (IP).
- Has been treated with an investigational agent (i.e., an agent not commercially available) within 28 days of initiating IP.
- Prior treatment of any inhibitors of PD-1 or PD-L1 within 3 months prior to initiating IP.
- 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.
- Subject known to test positive for human immunodeficiency virus, active hepatitis B, or active hepatitis C.
- Subject is unable or unwilling to undergo protocol required thromboembolism prophylaxis.
- Subject is a female who is pregnant, nursing, or breastfeeding.
Key Trial Info
Start Date :
September 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04283097
Start Date
September 13 2021
End Date
December 12 2024
Last Update
May 16 2025
Active Locations (10)
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1
UC Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
2
BRCR Global - USA
Plantation, Florida, United States, 33322
3
Norton Cancer Institute
Louisville, Kentucky, United States, 40202
4
Henry Ford Health System - Hemophilia and Thrombosis Treatment Center
Detroit, Michigan, United States, 48202-2689