What is the mechanism of action of this treatment?

APG-2575 is a BCL-2 inhibitor that works by inducing apoptosis in cancer cells, which is particularly relevant for patients with advanced solid tumors or ER+/HER2- metastatic breast cancer. Other common treatments include CDK 4/6 inhibitors like palbociclib, which block cell cycle progression, and HER2-targeted therapies such as trastuzumab, which inhibit HER2 signaling pathways. Endocrine therapies, including aromatase inhibitors and selective estrogen receptor modulators, reduce estrogen levels or block estrogen receptors to slow the growth of hormone receptor-positive breast cancer. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the specific characteristics of the cancer, potentially improving outcomes and minimizing side effects.

What side effects are associated with this type of intervention?

Common treatments for ER+/HER2- metastatic breast cancer, such as those involving CDK 4/6 inhibitors like palbociclib, often result in side effects including neutropenia, fatigue, nausea, and infections. Endocrine therapies like tamoxifen can cause hot flashes, vaginal dryness, and an increased risk of thromboembolic events, while aromatase inhibitors may lead to bone density loss, fractures, and cardiovascular risks. BCL-2 inhibitors like APG-2575, though still under investigation, may share similar side effects with these treatments, including hematologic toxicities and gastrointestinal disturbances.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of breast cancer, particularly for hormone receptor-positive (HR+) and HER2-negative (HER2-) subtypes. Notable approvals include CDK 4/6 inhibitors such as palbociclib, ribociclib, and abemaciclib, which are often used in combination with hormone therapies like letrozole or fulvestrant. These treatments have shown efficacy in managing advanced or metastatic breast cancer by inhibiting cell cycle progression. While specific BCL-2 inhibitors like APG-2575 are still under investigation, the use of targeted therapies in combination with other agents represents a significant advancement in breast cancer treatment.

What other types of research exist?

Promising novel alternatives to APG-2575 for breast cancer patients in 2024 include: 1) The combination of fulvestrant plus everolimus, which has shown safety and efficacy in hormone-receptor positive, HER2-negative metastatic breast cancer. 2) The pan-PI3K inhibitor buparlisib in combination with fulvestrant, which has demonstrated activity in clinical trials. 3) Talazoparib, a PARP inhibitor, which is particularly effective in BRCA-positive breast cancer and may have potential in broader applications beyond BRCA mutations.

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APG-2575 + Palbociclib for Breast Cancer

Phase 1 & 2

Waitlist Available

Led By Xuemi Sun, MD

Research Sponsored by Ascentage Pharma Group Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Brain metastases with clinically controlled neurologic symptoms

For patients with breast cancer: Must have histological or cytological confirmation of metastatic carcinoma of the breast with specific tumor molecular characteristics

Must not have

Prior use of a Bcl-2 inhibitor

Active symptomatic pathogenic infection including fungal, bacterial and/or viral infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is testing a new drug, APG-2575, alone or with another drug called palbociclib, in patients with advanced cancers that did not respond to initial treatments. The goal is to find the best dose and see if it can effectively treat these cancers.

Who is the study for?

This trial is for adults with advanced solid tumors lacking effective standard therapy, or those with specific types of metastatic breast cancer after first line therapy failure. Participants must be over 18, have adequate organ function, and not be pregnant. They should also agree to use contraception and be able to take oral tablets.

What is being tested?

The study is testing APG-2575 alone in patients with various solid tumors and in combination with Palbociclib for ER+/HER2- metastatic breast cancer patients who didn't respond well to initial treatments. It's an open-label phase Ib/II trial across multiple centers.

What are the potential side effects?

Potential side effects may include typical reactions related to anti-cancer medications such as nausea, fatigue, blood cell count changes, potential infection risks, and possibly unique effects from the new drug APG-2575 or its combination with Palbociclib.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My brain cancer has spread but my symptoms are under control.

Select...

My breast cancer has spread and has specific molecular features.

Select...

My cancer has no standard treatment options left, as confirmed by tests.

Select...

I can swallow pills without any issues.

Select...

I am fully active and can carry on all pre-disease activities without restriction.

Select...

I am in menopause naturally or through treatment.

Select...

I can provide a sample of my tumor for the study, either from previous tests or by undergoing a new biopsy.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have previously used a Bcl-2 inhibitor.

Select...

I am currently experiencing symptoms from a fungal, bacterial, or viral infection.

Select...

I still have side effects from previous cancer treatments that are moderate or worse.

Select...

I have a heart condition affecting my heart's electrical activity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DLT

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: single armExperimental Treatment1 Intervention

APG2575

Group II: combination armExperimental Treatment2 Interventions

APG2575+palbociclib i

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Palbociclib

FDA approved

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

APG-2575 is a BCL-2 inhibitor that works by inducing apoptosis in cancer cells, which is particularly relevant for patients with advanced solid tumors or ER+/HER2- metastatic breast cancer. Other common treatments include CDK 4/6 inhibitors like palbociclib, which block cell cycle progression, and HER2-targeted therapies such as trastuzumab, which inhibit HER2 signaling pathways. Endocrine therapies, including aromatase inhibitors and selective estrogen receptor modulators, reduce estrogen levels or block estrogen receptors to slow the growth of hormone receptor-positive breast cancer. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the specific characteristics of the cancer, potentially improving outcomes and minimizing side effects.

Stress Granules in the Anti-Cancer Medications Mechanism of Action: A Systematic Scoping Review.Management of Brain and Leptomeningeal Metastases from Breast Cancer.Challenges in the diagnosis and management of cervical neuroendocrine carcinoma.