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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial is testing a new drug, AZD8205, to see if it can shrink or slow the growth of certain types of cancer.

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.Check my eligibility

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.See study design

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

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I can carry out all my daily activities without help.

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I am 18 years old or older.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Disease Control Rate at 12 weeks (DCR-12)

Duration of response (DoR)

Immunogenicity of AZD8205.

+8 more

Trial Design

1Treatment 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.

0 / 2Eligibility criteria met

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Who is running the clinical trial?

AstraZenecaLead Sponsor

4,265 Previous Clinical Trials

288,605,034 Total Patients Enrolled

173 Trials studying Breast Cancer

1,246,091 Patients Enrolled for Breast Cancer

Media Library

AZD8205 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT05123482 — Phase 1 & 2

Breast Cancer Research Study Groups: Sub-Study 1 AZD8205 Monotherapy

Breast Cancer Clinical Trial 2023: AZD8205 Highlights & Side Effects. Trial Name: NCT05123482 — Phase 1 & 2

AZD8205 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05123482 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any US-based health facilities that are currently implementing this research?

"At this moment in time, six different medical sites are signing up participants for the trial. These locales include Houston, Santa Monica and Saint Louis with an additional trio of centres situated elsewhere. When selecting a site to join, it is recommended that you choose one geographically close by so as to minimize travel requirements during the study period."

Answered by AI

What is the maximum patient capacity for this clinical investigation?

"Affirmative. Clinicaltrials.gov indicates that this clinical trial, which was initially published on October 18th 2021 is still recruiting patients. The researchers need to find a total of 198 individuals from 6 distinct medical centres for their study."

Answered by AI

Are individuals able to join this medical research currently?

"The trial is actively seeking participants, as per the information available on clinicaltrials.gov. This medical study was initially published on October 18th 2021 and recently updated on October 31st 2022."

Answered by AI

What is the principal objective of this trial?

"The primary end-point of this clinical trial, measured within the confines of one year from informed consent until 30 days post last dose, will evaluate the amount of adverse events experienced by participants. Secondary objectives include Overall Survival (time between first medication administration and death), Pharmacokinetics Cmax values (maximum observed plasma concentration), and t 1/2 measurements (terminal elimination half life)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First in Human Study to Evaluate AZD8205 in Patients With Advanced or Metastatic Solid Malignancies

2021. "First in Human Study to Evaluate AZD8205 in Patients With Advanced or Metastatic Solid Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05123482.

All > Breast Cancer High Point > Bile Duct Cancer