New pill takes on Hard-to-Treat blood cancers
NCT ID NCT07424833
First seen Jun 25, 2026 · Last updated Jul 31, 2026 · Updated 3 times
Summary
This early-stage trial tests a daily pill called APG-3288 in 180 adults with blood cancers like leukemia or lymphoma that have come back or not responded to standard treatments. The main goals are to find the safest dose and check for side effects. Researchers will also look for any signs that the drug is shrinking tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- APG-3288
- What this could lead to
- If this trial succeeds, it could point toward a new treatment option for people with blood cancers that have not responded to other therapies.
- What could go wrong
- This is a very early Phase 1 study, so the main goal is safety, not effectiveness. The drug may not work or could cause serious side effects. It will take years before any potential treatment is available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Sign up to get updates when this study changes or when new studies for Relapsed/refractory chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL are added.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
6 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Henan Cancer Hospital
RECRUITINGZhengzhou, Henan, China
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Mayo Clinic
NOT_YET_RECRUITINGJacksonville, Florida, 32224, United States
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START Los Angele
RECRUITINGLos Angeles, California, 90025, United States
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START Midwest
RECRUITINGGrand Rapids, Michigan, 49546, United States
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START New Jersey
RECRUITINGEast Brunswick, New Jersey, 08816, United States
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The University of TX MD Anderson Cancer Center
NOT_YET_RECRUITINGHouston, Texas, 77030, United States
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