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New pill takes on Hard-to-Treat blood cancers

NCT ID NCT07424833

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Dec 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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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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.

  1. The places running it

    6 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Mayo Clinic

    NOT_YET_RECRUITING

    Jacksonville, Florida, 32224, United States

  • START Los Angele

    RECRUITING

    Los Angeles, California, 90025, United States

  • START Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • START New Jersey

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • The University of TX MD Anderson Cancer Center

    NOT_YET_RECRUITING

    Houston, Texas, 77030, United States

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