What's the purpose of this trial?
This is a Phase 1 study to evaluate the safety, pharmacokinetics(PK), and preliminary clinical activity of KPG-818 as a single agent in adult subjects with selected hematological malignancies, including multiple myeloma (MM), mantle cell lymphoma (MCL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), indolent lymphoma, adult T-cell leukemia-lymphoma (ATL), or chronic lymphocytic leukemia (CLL).
This trial is currently open and accepting patients.
What will happen during the trial?
This study will assist in identifying appropriate, well tolerated doses that can be administered in subsequent studies in subjects with selected hematological malignancies.
You may be able to join this trial if you:
The following criteria is a partial list of reasons why patients may be
eligible to participate in this clinical trial. Further evaluation with a medical professional is
- ≥ 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.
- 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.
Additional Trial Information
Enrollment: 56 patients (estimated)
Trial Sponsor: Kangpu Biopharmaceuticals, Ltd.
SparkCures Identifier: 1076