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AMXI-5001 for Advanced Cancers

Phase 1 & 2

Waitlist Available

Research Sponsored by AtlasMedx, Incorporated

Eligibility Criteria Checklist

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

Must have

Eastern Co-operative Oncology Group (ECOG) PS 0-1

Has evaluable or measurable tumor(s) in dose escalation by standard radiological and/or laboratory assessments as applicable to their malignancy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 24 months

Awards & highlights

Study Summary

This trial is testing a new cancer treatment called AMXI-5001 in adults who have unsuccessfully tried other treatments. The study has two parts: first, they're testing different doses to see what is safe and effective; second, they're expanding the study to see how well the treatment works.

Who is the study for?

This trial is for adults with advanced cancers like ovarian, prostate, pancreatic, or breast cancer that have worsened despite standard treatments. Participants must be over 18 and have a performance status indicating they can care for themselves (ECOG PS 0-1). They should not be on current cancer treatment and must not take certain drugs affecting liver enzymes.Check my eligibility

What is being tested?

AMXI-5001 is being tested in two phases: Phase I to find the right dose and Phase II to assess its safety and effectiveness. Patients with advanced malignancies who haven't responded well to other therapies are given escalating doses of AMXI-5001 until an optimal dose is found.See study design

What are the potential side effects?

While specific side effects of AMXI-5001 aren't listed here, common ones from similar trials may include nausea, fatigue, allergic reactions, blood count changes leading to increased infection risk or bleeding tendencies, liver function abnormalities, and potential heart issues.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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My cancer can be measured or evaluated using scans or tests.

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My cancer has worsened despite treatment.

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I am 18 years old or older.

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My cancer is advanced or has spread to other parts of my body.

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My cancer has not responded to any treatment known to work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 months for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Determine the Maximum Tolerated Dose (MTD)

Secondary outcome measures

Characterize safety profile of AMXI-5001

Determine change in anti-tumor activity following administration of AMXI-5001

Determine the Recommended Phase 2 Dose (RP2D) for AMXI-5001 as monotherapy

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: AMXI-5001 TreatmentExperimental Treatment2 Interventions

Single Arm Study, all participants will receive AMXI-5001.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

AtlasMedx, IncorporatedLead Sponsor

Pamela Munster, MDStudy DirectorAtlasMedx, Incorporated

12 Previous Clinical Trials

365 Total Patients Enrolled

Douglas Kramer, MDStudy DirectorAtlasMedx, Inc

1 Previous Clinical Trials

29 Total Patients Enrolled

Media Library

AMXI-5001 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04503265 — Phase 1 & 2

Ovarian Cancer Research Study Groups: AMXI-5001 Treatment

Ovarian Cancer Clinical Trial 2023: AMXI-5001 Highlights & Side Effects. Trial Name: NCT04503265 — Phase 1 & 2

AMXI-5001 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04503265 — 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 people currently being signed up for this experiment?

"Yes, as of 8/22/2022 this trial is still recruiting patients. The clinical study was initially posted on 8/12/2020 and has been openly accepting applications from willing participants. They are looking for a total of 80 people spread out across 8 different locations."

Answered by AI

Could you please list how many different hospitals are participating in this trial?

"Patients are being accepted at this trial's many locations, which include Moffitt Cancer Center and Research Institute in Tampa, Florida, Johns Hopkins in Baltimore, Maryland, Honor Health in Phoenix, Arizona among 8 other sites."

Answered by AI

How many test subjects are being enrolled in this research project?

"To satisfy the needs of this clinical trial, 80 individuals that meet specific inclusion criteria are required to participate. These patients can come from different places, such as Moffitt Cancer Center and Research Institute in Tampa, Florida or Johns Hopkins in Baltimore, Maryland."

Answered by AI

Recent research and studies

Clinical Cancer ResearchJournal

BMN 673, a Novel and Highly Potent PARP1/2 Inhibitor for the Treatment of Human Cancers with DNA Repair Deficiency

Shen, Yuqiao, Farah L. Rehman, Ying Feng, Julia Boshuizen, Ilirjana Bajrami, Richard Elliott, Bing Wang, Christopher J. Lord, Leonard E. Post, and Alan Ashworth. 2013. “BMN 673, a Novel and Highly Potent PARP1/2 Inhibitor for the Treatment of Human Cancers with DNA Repair Deficiency”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-13-1391.

clinicaltrials.govStudy

A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies

2020. "A Trial of AMXI-5001 for Treatment in Patients With Advanced Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04503265.

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