Relapsed/Refractory Hematological Malignancies study: APG-3288
Official title A Study of APG-3288 in Relapsed/Refractory Blood Cancers
ClinicalTrials.gov ID: NCT07424833
What this study is testing
What is APG-3288?
An investigational oral medicine being studied for relapsed or refractory blood cancers.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find the safest dose of APG‑3288 that can be given by mouth once a day and to recommend a dose for future studies.
- Who it's for
- It looks for adults with various relapsed or refractory blood cancers, such as chronic lymphocytic leukemia, diffuse large B‑cell lymphoma, mantle cell lymphoma, Waldenström macroglobulinemia, marginal zone lymphoma, or follicular lymphoma.
- What's involved
- Participants will take APG‑3288 by mouth every day and will have regular clinic visits and tests to monitor safety and side effects.
- Time commitment
- The study lasts several months, with scheduled visits for dose adjustments and safety monitoring.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Prior systemic therapy: at least 2 prior lines of systemic therapy (including BTK inhibitor for approved indications) and who have failed or are not...
- Measurable disease per response criteria specific to the malignant condition.
- Adequate organ and bone marrow function. Key
You likely can't join if
- Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, targeted therapy, biologic therapy, with...
- Any investigational therapy within 14 days prior to the first dose of study drug or within 5 half-lives of the respective investigational drug...
- Persistent toxicities from prior radiotherapy, targeted therapy, immunotherapy, or chemotherapy agents that have not recovered to Grade \<2 (except...
- Symptomatic brain metastases due to tumor involvement of the central nervous system (CNS).
- Use of therapeutic-dose anticoagulants or antiplatelet agents. (Use of low-dose anticoagulants to maintain central venous catheter patency is...
- Biological growth factors within 7 days prior to the first dose of study drug.
See the full eligibility 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
- 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...
- 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...
- 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.
- New York Heart Association class III or IV cardiac disease, including pre-existing uncontrolled, clinically-significant arrhythmia, congestive heart failure, or cardiomyopathy.
- Unstable angina, myocardial infarction, or a coronary revascularization procedure within ≤ 3 months prior to initiation of study treatment.
- History of left ventricular ejection fraction \< 50%.
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Jacksonville, Florida, United States
- Grand Rapids, Michigan, United States
- East Brunswick, New Jersey, United States
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Jacksonville, Florida, United States; Grand Rapids, Michigan, United States; East Brunswick, New Jersey, United States; Zhengzhou, Henan, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.