What side effects are associated with this type of intervention?

Common treatments for HER2-positive breast cancer, such as trastuzumab, lapatinib, and T-DM1, have several known side effects. Trastuzumab can cause cardiotoxicity, leading to heart issues. Lapatinib is associated with gastrointestinal side effects like diarrhea, nausea, and vomiting. T-DM1 can cause decreased neutrophil count, anemia, nausea, and interstitial lung disease. These side effects should be carefully monitored during treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for HER2-positive breast cancer, which target the HER2 receptor similar to DZD1516. These include trastuzumab, a monoclonal antibody that inhibits HER2; pertuzumab, which also targets HER2 and is often used in combination with trastuzumab; fam-trastuzumab deruxtecan, an antibody-drug conjugate that combines trastuzumab with a chemotherapy drug; and trastuzumab-emtansine (T-DM1), another antibody-drug conjugate that links trastuzumab to the cytotoxic agent emtansine. These treatments have shown efficacy in various stages of HER2-positive breast cancer, including metastatic cases.

What other types of research exist?

Promising alternatives to DZD1516 for HER2-positive breast cancer patients include LJM716, an anti-HER3 monoclonal antibody, and the combination of Palbociclib and Fulvestrant for ER+/HER2- advanced/metastatic breast cancer. Additionally, trastuzumab deruxtecan (Enhertu) has shown efficacy in HER2-mutant cancers and could be considered.

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Tyrosine Kinase Inhibitor

DZD1516 Combinations for HER2 Positive Breast Cancer

Phase 1

Waitlist Available

Led By McAndrew

Research Sponsored by Dizal Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

Histologically or cytologically confirmed HER2 positive advanced breast cancer which failed prior therapies

Be older than 18 years old

Must not have

Any evidence of severe or uncontrolled systemic diseases

Major surgery procedure (excluding placement of vascular access), or significant traumatic injury within 4 weeks of the first dose of study treatment, or have an anticipated need for major surgery during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new pill called DZD1516 for patients with advanced HER2 positive breast cancer that has spread and didn't respond to other treatments. The pill works by blocking a protein that helps cancer cells grow. The study will check for side effects and see how well the drug works alone or with other treatments.

Who is the study for?

This trial is for adults over 18 with advanced HER2 positive breast cancer that didn't respond to previous treatments. Participants must have a certain level of physical fitness (ECOG status), measurable cancer lesions, and a life expectancy of at least 12 weeks. They can't join if they've had recent chemotherapy, live vaccines, major surgery, or suffer from severe diseases or infections like TB or hepatitis.

What is being tested?

The study tests DZD1516, an oral drug designed to penetrate the brain barrier and inhibit HER2 in metastatic breast cancer. It's being tried alone (Part A) and combined with trastuzumab/capecitabine (Part B) or T-DM1 (Part C). This is its first use in humans to assess safety, tolerability, drug levels in the body, and anti-cancer effects.

What are the potential side effects?

Since this is DZD1516's first trial in humans, specific side effects are unknown but may include typical reactions related to cancer therapies such as nausea, fatigue, blood disorders and potential organ inflammation due to its mechanism as a tyrosine kinase inhibitor.

Eligibility Criteria

Inclusion Criteria

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

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My advanced breast cancer is HER2 positive and did not respond to previous treatments.

Exclusion Criteria

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

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I do not have any severe or uncontrolled illnesses.

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I haven't had major surgery or significant injury in the last 4 weeks and don't expect to need major surgery during the study.

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I do not have active infections like TB, hepatitis B, hepatitis C, or HIV.

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I haven't had chemotherapy injected into my spine in the last 2 weeks.

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I need urgent brain surgery due to complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Incidence of dose limiting toxicities (DLTs)

To define Recommended Phase II Combination Dose (RP2CD) of DZD1516 in combination with T-DM1 (Part C only)

+2 more

Secondary study objectives

Area under the plasma concentration-time curve (AUC) of DZD1516 and its metabolite DZ2678

Disease Control Rate (DCR)

Drug concentrations of DZD1516 and its metabolite DZ2678 in plasma, urine and CSF

+9 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: daily dose of DZD1516Experimental Treatment1 Intervention

daily dose of DZD1516

0 / 6Eligibility 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

HER2-targeted therapies, such as tyrosine kinase inhibitors (TKIs) and antibody-drug conjugates (ADCs), play a crucial role in treating HER2-positive breast cancer. TKIs, like DZD1516, inhibit the HER2 receptor's tyrosine kinase activity, blocking downstream signaling pathways that promote cancer cell growth and survival. ADCs, such as trastuzumab deruxtecan, combine the specificity of antibodies targeting HER2 with potent cytotoxic agents, delivering the drug directly to cancer cells and minimizing damage to normal cells. These mechanisms are vital for breast cancer patients as they offer targeted treatment options that can improve outcomes and reduce side effects compared to traditional chemotherapy.

Do our current clinical trial designs help to guide clinical practice?New drugs for breast cancer.Endocrine therapy for early breast cancer.