APG-3288 for Blood Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new pill, APG-3288, for treating certain types of blood cancer that have returned or don't respond to treatment. Researchers aim to find the safest and most effective dose of the drug. The trial consists of two parts: first, they will test different doses to determine which works best with minimal side effects, and then they will further evaluate that chosen dose. Individuals who have undergone at least two different treatment plans for their blood cancer and are not eligible for other proven therapies might be suitable for this trial. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications for the trial?
The trial requires you to stop any current anti-cancer therapy and certain other medications, like therapeutic-dose anticoagulants and QT-prolonging medications. If you're on investigational therapy, you need to stop it at least 14 days before starting the trial. Always discuss with the trial team to understand how your specific medications might be affected.
Is there any evidence suggesting that APG-3288 is likely to be safe for humans?
Research has shown that APG-3288 is being tested for blood cancers that have returned or don't respond to other treatments. As this is an early-stage study, the main goal is to determine the safe dosage for patients.
Previous patients have demonstrated that APG-3288 targets specific cancer cells, and researchers are closely monitoring its effects on the body. The drug's safety remains under study, with scientists working to find the optimal dose that patients can tolerate without serious side effects.
As a Phase 1 trial, APG-3288 is being tested in humans for the first time. While detailed information on tolerance is not yet available, the trial aims to ensure that any side effects remain manageable. Participants in this study will help researchers learn more about the treatment's safety.12345Why do researchers think this study treatment might be promising?
Most treatments for blood cancer, like chemotherapy and targeted therapies, aim to kill cancer cells or block signals that help them grow. But APG-3288 works differently, targeting specific proteins involved in the survival and proliferation of cancer cells, potentially offering a more precise approach. Researchers are excited about APG-3288 because it could offer a novel mechanism of action that might be more effective for certain patients, especially those who haven't responded well to existing therapies. Additionally, this treatment might have a different side effect profile, which could improve patients' quality of life during treatment.
What evidence suggests that APG-3288 might be an effective treatment for blood cancer?
Research on APG-3288 remains in the early stages, with limited information from human studies. This trial will evaluate APG-3288 in two phases: a Dose Escalation Phase to determine the recommended phase 2 dose or maximum tolerated dose, and a Dose Expansion Phase to further assess its effectiveness. APG-3288 targets specific proteins in cancer cells that aid their survival. By blocking these proteins, APG-3288 aims to halt cancer growth. Early lab tests and initial patient results suggest it might be effective against some blood cancers. While promising, further research is necessary to confirm its efficacy.678910
Who Is on the Research Team?
Keshu Zhou, M.D.,Ph.D.
Principal Investigator
Henan Cancer Hospital
Are You a Good Fit for This Trial?
This trial is for adults with certain blood cancers (like lymphoma or leukemia) that have come back or didn't respond to treatment. Participants must have tried at least two previous treatments, have measurable disease, and their organs need to be working well.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation Phase
Participants receive orally administered APG-3288 at specified doses once daily in 28-day cycles to determine the MTD or RP2D
Dose Expansion Phase
Further evaluation of dose safety with up to 60 patients per chosen indication enrolled and randomly assigned to dose cohorts
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- APG-3288
Trial Overview
The study tests APG-3288, a new oral drug taken once daily by itself. The main goal is to find the safest dose for people with relapsed or hard-to-treat blood cancers. All participants receive the same experimental medicine.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Indications and dose cohorts to be determined from Part 1
APG-3288 at multiple dose levels will be evaluated to determine the recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ascentage Pharma Group Inc.
Lead Sponsor
Citations
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A Study of APG-3288 in Relapsed/Refractory Blood Cancers
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 ...
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ascentage.com
ascentage.com/ascentage-pharma-announces-ind-clearance-by-the-u-s-food-and-drug-administration-for-btk-degrader-apg-3288/Ascentage Pharma Announces IND Clearance by the U.S. ...
Novel next-generation Bruton tyrosine kinase (BTK)-targeted protein degrader APG-3288 has received investigational new drug (IND) clearance ...
8.
veterans.networkofcare.org
veterans.networkofcare.org/cecil-md/CommunityResources/ClinicalTrials/Detail/NCT07424833?keyword=%22MCL%22A Study of APG-3288 in Relapsed/Refractory Blood Cancers
Doses will be determined based on a comprehensive assessment of the pharmacokinetic (PK), pharmacodynamic (PD), safety, and efficacy data of APG-3288 from Part ...
9.
ascentage.com
ascentage.com/ascentage-pharma-announces-ind-clearance-by-the-china-cde-for-btk-degrader-apg-3288/Ascentage Pharma Announces IND Clearance by the ...
... safety, tolerability, pharmacokinetic (PK) profile, and ... APG-3288 in patients with relapsed/refractory hematologic malignancies.
10.
withpower.com
withpower.com/trial/phase-1-relapsedrefractory-marginal-zone-lymphoma-mzl-2-2026-a477eAPG-3288 for Blood Cancer · Info for Participants
This Phase 1 medical study run by Ascentage Pharma Group Inc. needs participants to evaluate whether APG-3288 will have tolerable side effects & efficacy ...
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