A Study of APG-3288 in Relapsed/Refractory Blood Cancers
A Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of APG-3288 in Patients With Relapsed/Refractory Hematological Malignancies
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests APG-3288, taken by mouth once a day, for blood cancers that came back or did not respond to treatment. It aims to find the highest dose patients can tolerate and a dose to use in future studies.
This is a Phase I, multicenter, open-label, two-stage study of APG-3288 monotherapy, aiming to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of APG-3288 administered orally once daily in patients with relapsed/refractory (R/R) hematologic malignancies.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- For Part 1, have one of these confirmed blood cancers: CLL/SLL, diffuse large B-cell lymphoma (including Richter transformation), mantle cell lymphoma, Waldenström macroglobulinemia, marginal zone lymphoma, or follicular lymphoma.
- For Part 1, be fully active or have trouble only with hard physical activity. For Part 2, be able to care for yourself and be out of bed more than half the day.
- Have had at least 2 rounds of treatment plans for your cancer, including a BTK inhibitor, a targeted cancer drug, when approved for your cancer.
- Have tried available treatments with proven benefit without success, or be unable to receive them.
- Have cancer that can be measured using the study’s rules for your cancer type.
- Have organs and bone marrow, which makes blood cells, working well enough.
Who can't join
- You are receiving another cancer treatment. Some hormone medicines are allowed. Recent experimental treatment is also excluded: within 14 days or 5 drug half-lives, whichever is shorter. A half-life is the time for half the drug to leave your body.
- You still have more than mild side effects from past cancer treatment, except hair loss or loss of skin color. You have not healed enough from surgery, or had major surgery within 28 days or minor surgery within 14 days before joining.
- You have cancer in the brain causing symptoms. Treated brain or spinal cord tumors may be allowed if you have no symptoms and stopped steroids for them more than 28 days ago.
- You use treatment-dose blood thinners or medicines that stop blood cells from clotting. Low doses to keep a central IV line open are allowed. You received growth factors, medicines that help make blood cells, within 7 days before the first study dose.
- You have serious heart disease, poorly controlled blood pressure, or a history of not taking blood pressure medicines as directed. Certain recent heart problems, weak heart pumping, medicines that affect heart rhythm, or a past dangerous rhythm called torsades de pointes also exclude you.
- You have an uncontrolled infection causing symptoms, an autoimmune disease in which the body attacks itself, active bowel inflammation, a long-term infection, or another condition causing long-term inflammation. Well-controlled HIV or hepatitis B or C may be allowed.
- You have another cancer, with exceptions for cancer cured without return for 3 years, certain fully removed skin cancers, or fully removed cancer that has not spread beyond where it started. Other severe or uncontrolled health problems may also exclude you.
- You previously received a BTK degrader, a drug that breaks down a protein in cancer cells, or a stem cell transplant from a donor.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Key Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) status ≤ 1 in Part 1 (dose escalation), and ≤ 2 in Part 2 (dose expansion). * Part 1 (Dose Escalation): histologically or cytologically confirmed diagnosis of R/R CLL/SLL, DLBCL (including Richter Transformation), MCL, WM, MZL, or FL. * Prior systemic therapy: at least 2 prior lines of systemic therapy (including BTK inhibitor for approved indications) and who have failed or are not eligible for available therapies with established clinical benefit. * Measurable disease per response criteria specific to the malignant condition. * Adequate organ and bone marrow function. Key Exclusion Criteria: * Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, with the exception of hormones for hypothyroidism or estrogen replacement therapy, anti-estrogen analogs, agonists required to suppress serum testosterone levels). * Any investigational therapy within 14 days prior to the first dose of study drug or within 5 half-lives of the respective investigational drug (whichever is shorter). * Persistent toxicities from prior radiotherapy, targeted therapy, immunotherapy, or chemotherapy agents that have not recovered to Grade \<2 (except for alopecia or vitiligo). * Symptomatic brain metastases due to tumor involvement of the central nervous system (CNS). Patients with CNS tumors who have been treated, are asymptomatic, and who have discontinued steroids (for the treatment of CNS tumors) for \> 28 days may be enrolled. * Use of therapeutic-dose anticoagulants or antiplatelet agents. (Use of low-dose anticoagulants to maintain central venous catheter patency is permitted) * Biological growth factors within 7 days prior to the first dose of study drug. * Patients who, in the investigator's judgment, have not adequately recovered from prior surgery, or have undergone major surgery within 28 days prior to enrollment, or minor surgery within 14 days prior to enrollment. * Significant cardiac disease defined as: 1. New York Heart Association class III or IV cardiac disease, including pre-existing uncontrolled, clinically-significant arrhythmia, congestive heart failure, or cardiomyopathy. 2. Unstable angina, myocardial infarction, or a coronary revascularization procedure within ≤ 3 months prior to initiation of study treatment. 3. History of left ventricular ejection fraction \< 50%. 4. Poorly controlled hypertension, or history of poor compliance with antihypertensive drug regimens. * Clinically active and uncontrolled symptomatic infection; well-controlled human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection may be considered for enrollment. * Autoimmune diseases, active inflammatory bowel disease, chronic infections, or any other disease or condition associated with chronic inflammation. * Concurrent use of QT-prolonging medications or history of torsades de pointes. * Concurrent malignancy other than the one being treated in this study with the exception of the following: cured malignancy without recurrence within 3 years prior to study entry; completely resected basal cell and squamous cell skin cancer; completely resected carcinoma in situ of any type. * Any severe and/or uncontrolled medical condition that, in the investigator's opinion, may compromise the individual's safety or the evaluation of study results. * Prior treatment with: BTK degrader treatment or allogeneic stem cell transplant
Study sites (5)
CA
- START Los Angele · Los Angeles, CA 90025More trials in Los Angeles
FL
- Mayo Clinic · Jacksonville, FL 32224More trials in Jacksonville
MI
- START Midwest · Grand Rapids, MI 49546More trials in Grand Rapids
NJ
- START New Jersey · East Brunswick, NJ 08816More trials in East Brunswick
TX
- The University of TX MD Anderson Cancer Center · Houston, TX 77030More trials in Houston