A Study of Safety, Tolerability, Pharmacokinetic and Pharmacodynamics (PK/PD) in Patients With Hematologic Malignancies

Overview

About this study

The purpose of this study is to evaluate the safety and tolerability of APG-2575 as well as dose escalation and dose expansion stages.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Age ≥18 years old.

2. Histologically confirmed diagnosis of either one of the B-cell hematologic
malignancies including multiple myeloma, chronic lymphocytic leukemia,
lymphoplasmacytic lymphoma, and non-Hodgkin's lymphoma such as mantle cell lymphoma,
diffuse large B cell lymphoma, Waldenstrom macroglobulinemia (WM) and acute myeloid
leukemia

3. Patient must have relapsed or refractory to, intolerant to, or are considered
ineligible for therapies known to provide clinical benefit. In addition,

a. AML Patients will be eligible if they have failed standard induction regimen, are
not considered candidate for further chemotherapy or stem cell transplantation or have
primary refractory AML.

4. Life expectancy ≥ 3 months.

5. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS): 0 -1 in dose
escalation ; 0-2 in dose expansion.

6. QTc interval ≤450ms in males, and ≤470ms in females.

7. Adequate bone marrow function independent of growth factor:

8. Absolute neutrophil count (ANC) ≥1.0 X 109/L.

9. Hemoglobin ≥ 8.0 g/dL.

10. Platelets count ≥ 30 X 109/L (entry platelet count must be independent of transfusion
within 7 days of first dose).

11. Adequate renal and liver function as indicated by:

Exclusion Criteria:

Patients who meet any of the following exclusion criteria are not to be enrolled in this
study:

1. Prior history of allogeneic cell transplant.

2. Subjects have been diagnosed with Burkitt's lymphoma, Burkitt-like lymphoma, or
lymphoblastic lymphoma/leukemia.

3. Received chemotherapy within 14 days (42 days for nitrosoureas or mitomycin C) prior
to entering the study.

4. Received biologic (< 28 days), small molecule targeted therapies (< 5 half-life) or
other anti-cancer therapy within 21 days of study entry.

5. Radiation within 14 days of study entry, thoracic radiation within 28 days of study
entry.

6. Has gastrointestinal conditions that could affect the absorption of APG-2575 in the
opinion of the Investigator.

7. Has known active central nervous system (CNS) involvement.

8. Continuance of toxicities due to prior radiotherapy or chemotherapy agents that do not
recover to ≤ Grade 1 except alopecia or neuropathy.

9. Concurrent treatment with an investigational agent, 14 days for small molecular agents
and/or 28 days for biologics treatment prior to the first dose of therapy.

10. Failure to recover adequately, as judged by the investigator, from prior surgical
procedures. Patients with active wound healing, patients who have had major surgery
within 28 days from study entry, and patients who have had minor surgery within 14
days of study entry.

11. Unstable angina, myocardial infarction, or a coronary revascularization procedure
within 180 days of study entry.

12. Active rheumatoid arthritis (RA), active inflammatory bowel disease, chronic
infections, or any other disease or condition associated with chronic inflammation.

13. Active infection requiring systemic antibiotic/ antifungal medication, known
clinically active hepatitis B or C infection, or on antiretroviral therapy for HIV
disease.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 8/31/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Sameer Parikh, M.B.B.S.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Jose Leis, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Jacksonville, Fla.

Mayo Clinic principal investigator

Sikander Ailawadhi, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.

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