What side effects are associated with this type of intervention?

Common treatments for breast cancer, especially targeted therapies like those studied in the AZD8205 trial, often include agents such as trastuzumab and capivasertib. The known side effects of these treatments can include diarrhea, fatigue, stomatitis, and cardiovascular issues. Additionally, chemotherapy agents like paclitaxel, often used in combination with targeted therapies, can cause neuropathy, myelosuppression, alopecia, and gastrointestinal disturbances. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Several targeted therapies have been approved by the FDA for the treatment of breast cancer. HER2 inhibitors such as trastuzumab, pertuzumab, and ado-trastuzumab emtansine target the HER2 protein, which promotes the growth of cancer cells. CDK4/6 inhibitors like palbociclib, ribociclib, and abemaciclib interfere with proteins that drive cell division. Additionally, PI3K inhibitors such as alpelisib target the PI3K pathway, which is involved in cell growth and survival. These therapies are designed to specifically target and inhibit pathways critical to tumor growth and metastasis, similar to the investigational agent AZD8205.

What other types of research exist?

Promising novel alternatives to AZD8205 for breast cancer patients in 2024 include: 1) Trastuzumab Deruxtecan (Enhertu), an antibody-drug conjugate targeting HER2-positive breast cancer. 2) Sacituzumab Govitecan (Trodelvy), an antibody-drug conjugate targeting Trop-2 in triple-negative breast cancer. 3) Alpelisib (Piqray), a PI3K inhibitor for HR-positive, HER2-negative breast cancer with PIK3CA mutations. 4) Pembrolizumab (Keytruda), an immune checkpoint inhibitor for PD-L1 positive breast cancer. These therapies have shown significant efficacy in clinical trials and are considered promising for future treatment options.

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Unknown

AZD8205 for Endometrial Cancer

Phase 1 & 2

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1

Age ≥ 18 years

Must not have

Treatment with any of the following: Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 28 days (whichever is shorter) prior to the first dose of study treatment Any other anticancer treatment within the following time periods prior to the first dose of study intervention: Cytotoxic treatment: 21 days Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter) Biological products including immuno-oncology agents: 28 days Spinal cord compression or a history of leptomeningeal carcinomatosis. Brain metastases unless treated, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent for at least 4 weeks prior to start of study. Active infection including tuberculosis and HBV, HCV or HIV History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses Participants with any of the following cardiac criteria: History of arrhythmia which is symptomatic or requires treatment (NCI CTCAE v5.0 Grade 3); symptomatic or uncontrolled atrial fibrillation, or asymptomatic sustained ventricular tachycardia. Uncontrolled hypertension. Acute coronary syndrome/acute myocardial infarction, unstable angina pectoris, coronary intervention procedure with percutaneous coronary intervention, or coronary artery bypass grafting within 6 months. History of brain perfusion problems (eg, carotid stenosis) or stroke, or transient ischemic attack in the last 6 months prior to screening. Symptomatic heart failure (NYHA class ≥ 2). Prior or current cardiomyopathy. Severe valvular heart disease. Mean resting QTcF > 470 msec. Risk factors for QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first dose of azd8205 to death ( approx. 2 years )

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called AZD8205 to see if it can help treat advanced or spreading solid tumors. The study includes patients whose cancer is advanced or has spread and may not respond to current treatments. AZD8205 might work by stopping or slowing down the growth of cancer cells.

Who is the study for?

Adults (18+) with advanced or metastatic solid tumors, specifically breast cancer, ovarian cancer, bile duct cancer (cholangiocarcinoma), or endometrial cancer. Participants must have measurable disease and an ECOG performance status of 0-1. They should expect to live at least 12 weeks and have proper organ/marrow function. Prior treatments vary by sub-study group.

What is being tested?

The trial is testing AZD8205 for patients with certain types of advanced cancers that have spread beyond the original site. It's a first-in-human study to see if this new compound can be effective in treating these conditions.

What are the potential side effects?

While specific side effects for AZD8205 are not listed here, common ones for similar drugs include nausea, fatigue, risk of infection due to low blood cell counts, liver issues, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can carry out all my daily activities without help.

Select...

I am 18 years old or older.

Exclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first dose of azd8205 to death ( approx. 2 years )

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first dose of azd8205 to death ( approx. 2 years )

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first dose of azd8205 to death ( approx. 2 years ) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

The number of patients with adverse events

The number of patients with changes from baseline laboratory findings, ECGs and vital signs

The number of patients with dose-limiting toxicity (DLT), as defined in the protocol.

+1 more

Secondary study objectives

Disease Control Rate at 12 weeks (DCR-12)

Duration of response (DoR)

Immunogenicity of AZD8205.

+10 more

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: Sub-Study 1 AZD8205 MonotherapyExperimental Treatment1 Intervention

Sub-Study 1 has two parts: Part A : The aim is to determine the safety, tolerability, Recommended Phase 2 Dose(RP2D), and/or the Maximum Tolerated Dose (MTD) of AZD8205. Part B: The aim of dose expansion is to evaluate anti-tumor activity of AZD8205 as monotherapy in select solid tumors.

Group II: Sub Study 2: AZD8205 in combination with rilvegostomigExperimental Treatment1 Intervention

Sub-Study 2 has two parts: Part A : Dose escalation to determine the safety, tolerability of AZD8205 + rilvegostomig Part B: Dose expansion to evaluate anti-tumor activity of AZD8205 + rilvegostomig in select solid tumors.

0 / 3Eligibility 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

Targeted therapies for breast cancer, such as those being studied in the trial AZD8205, work by inhibiting specific molecular pathways that are crucial for tumor growth and metastasis. These therapies often target proteins or genes that are overexpressed or mutated in cancer cells, such as HER2, CDK4/6, and mTOR. By blocking these pathways, targeted therapies can effectively slow down or stop the proliferation of cancer cells while minimizing damage to normal cells. This precision in treatment is particularly important for breast cancer patients as it can lead to better outcomes, fewer side effects, and a higher quality of life compared to traditional chemotherapy.

Breast Cancer Resistance to Cyclin-Dependent Kinases 4/6 Inhibitors: Intricacy of the Molecular Mechanisms.Pharmacokinetics, clinical indications, and resistance mechanisms in molecular targeted therapies in cancer.The emergence of targeted drugs in breast cancer to prevent resistance to endocrine treatment and chemotherapy.