Safety, Tolerability and Pharmacokinetics Study of KPG-818 in Hematological Malignancies Subjects

Completed · Phase 1

Conditions studied: Hematological Malignancies

In brief

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 \[SLL\]).

Key facts

Study ID

NCT04283097

Run by

Kangpu Biopharmaceuticals, Ltd.

People needed

30

Starts

2021-09-13

Expected to finish

2024-12-12

Last updated by the study team

2025-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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 may not qualify 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.
• 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.

Where it is running

• UC Davis Comprehensive Cancer Center — Sacramento, California, United States
• BRCR Global - USA — Plantation, Florida, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Henry Ford Health System - Hemophilia and Thrombosis Treatment Center — Detroit, Michigan, United States
• Mohamad Medical Cherry — Morristown, New Jersey, United States
• Duke University Health System - Duke Endoscopy - Duke Clinic 2H — Durham, North Carolina, United States
• Providence Portland Medical Center — Portland, Oregon, United States
• UPMC CancerCenter — Pittsburgh, Pennsylvania, United States
• Laguna Clinical Research Associates — Laredo, Texas, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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