What side effects are associated with this type of intervention?

Common treatments for breast cancer, including chemotherapy, endocrine therapy, and targeted therapy, have a range of side effects. Chemotherapy can cause alopecia, neurotoxicity, granulocytopenia, anemia, and gastrointestinal issues. Endocrine therapies like tamoxifen and aromatase inhibitors can lead to hot flashes, bone density loss, cardiovascular risks, and, in some cases, mild headaches. Targeted therapies may cause specific side effects depending on the drug, such as skin rashes or fatigue. It's important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of breast cancer, including aromatase inhibitors like letrozole and anastrozole, which reduce estrogen production and are used in hormone receptor-positive breast cancer. Additionally, CDK4/6 inhibitors such as palbociclib, ribociclib, and abemaciclib have been approved for their role in inhibiting cell cycle progression in cancer cells. HER2-targeted therapies, including trastuzumab and pertuzumab, are also significant in treating HER2-positive breast cancer. These treatments, while not identical to AO-252, share a common goal of targeting specific pathways involved in cancer cell growth and proliferation.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: 1) Immunotherapy agents such as pembrolizumab and atezolizumab, which target PD-1/PD-L1 pathways. 2) PARP inhibitors like olaparib and talazoparib for patients with BRCA mutations. 3) CDK4/6 inhibitors such as palbociclib, ribociclib, and abemaciclib, which are effective in hormone receptor-positive breast cancer. 4) Antibody-drug conjugates like trastuzumab deruxtecan for HER2-positive breast cancer. These therapies have shown promising results in clinical trials and are considered effective options for breast cancer treatment.

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Protein-Protein Interaction Inhibitor

AO-252 for Cancer

Phase 1

Recruiting

Research Sponsored by A2A Pharmaceuticals Inc.

Eligibility Criteria Checklist

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

Must have

Patients with TNBC, platinum-resistant HGSOC, primary peritoneal cancer, and/or fallopian-tube cancer, or serous endometrial cancer as described below

Patients with TNBC must have histologically or cytologically confirmed metastatic or locally recurrent unresectable TNBC per American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) criteria, with TP53 mutation/loss, and be relapsed/refractory to at least 1 line of systemic chemotherapy in the metastatic setting or be intolerant of existing therapy(ies)

Must not have

Patients with untreated or symptomatic brain metastases and/or leptomeningeal disease

Patients with uncontrolled pleural effusions, pericardial effusion, or ascites that do not resolve

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, AO-252, for safety and effectiveness in patients with advanced or hard-to-treat cancers like TNBC, HGSOC, and endometrial cancer. Researchers will study how the drug works in the body and its potential to reduce tumors.

Who is the study for?

This trial is for adults with certain advanced solid tumors like TNBC, ovarian, peritoneal, fallopian-tube or serous endometrial cancer. Participants must have specific genetic mutations (TP53), be past a first line of chemotherapy and not suitable for standard treatments. They need to be relatively healthy otherwise, not pregnant or breastfeeding, willing to use contraception and without recent other cancers or serious illnesses.

What is being tested?

The study tests AO-252, an oral drug for advanced solid tumors. It aims to find the safest and most effective dose. The focus is on how well patients tolerate it and its impact on their cancer.

What are the potential side effects?

While the side effects of AO-252 are being studied in this trial and aren't fully known yet, common risks may include reactions at the medication site, fatigue, nausea or other digestive issues as typically seen with new cancer drugs.

Eligibility Criteria

Inclusion Criteria

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

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I have TNBC, HGSOC, primary peritoneal, fallopian-tube, or serous endometrial cancer.

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My TNBC is confirmed, cannot be surgically removed, has a TP53 mutation, and hasn't responded to or I can't tolerate at least one chemotherapy.

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I can carry out all my usual activities without help.

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My cancer is resistant to platinum treatment, has spread, and lacks other treatment options.

Exclusion Criteria

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

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I have brain metastases or leptomeningeal disease that hasn't been treated or is causing symptoms.

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I have fluid buildup that hasn't improved with treatment.

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I cannot take pills due to my stomach or intestine problems.

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I have not had radiation to more than 30% of my bone marrow.

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I have hepatitis C that hasn't been treated, or I'm currently treating it with an undetectable viral load.

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I am on long-term steroids or other drugs that weaken my immune system.

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I haven't had cancer treatment in the last 3 weeks or 5 half-lives, whichever is shorter.

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I have had another type of cancer within the last 3 years.

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I have an active autoimmune disease or a history of one.

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I am not pregnant or breastfeeding and use effective birth control.

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I have HIV, HBV, or HCV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Safety Assessments [Dose escalation and Dose expansion]

Safety Assessments [Dose escalation]

Secondary study objectives

Antitumor Activity of AO-252 [Dose escalation and Dose expansion]

Pharmacokinetic Profile of AO-252 [Dose escalation and Dose expansion]

Awards & Highlights

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: Part 2: Dose ExpansionExperimental Treatment1 Intervention

After doses are decided in Part 1, participants entering part 2 will be assigned to a dose level.

Group II: Part 1: Dose EscalationExperimental Treatment1 Intervention

Participants will be assigned to dose levels.

0 / 15Eligibility 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

Common treatments for breast cancer include chemotherapy, hormonal therapy, and targeted therapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, through various mechanisms such as DNA damage or inhibition of cell division. Hormonal therapies, like aromatase inhibitors, reduce estrogen levels or block estrogen receptors, which is crucial for hormone receptor-positive breast cancers. Targeted therapies, such as HER2 inhibitors, specifically target molecules involved in cancer cell growth and survival. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the cancer's specific characteristics, potentially improving outcomes and minimizing side effects.

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