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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.
Must not have
Any clinically significant disease or condition affecting a major organ system
Significant cardiovascular disease or electrocardiogram (ECG) abnormalities
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new drug, AMXI-5001, for adults with advanced cancers who haven't been helped by other treatments. The drug is taken by mouth and works by stopping cancer cells from repairing and growing. The study aims to find the best dose and see how safe and effective the drug is.

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.
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.
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.

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 major organ system diseases.
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I do not have serious heart disease or abnormal heart tests.
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I am currently undergoing cancer treatment.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Determine the Maximum Tolerated Dose (MTD)
Secondary study objectives
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

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: AMXI-5001 TreatmentExperimental Treatment2 Interventions
Single Arm Study, all participants will receive AMXI-5001.

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 ovarian cancer include chemotherapy, targeted therapy, and investigational agents like AMXI-5001. Chemotherapy drugs, such as carboplatin and paclitaxel, work by damaging the DNA of cancer cells, preventing them from dividing and growing. Targeted therapies, like bevacizumab, inhibit angiogenesis, the process by which tumors develop new blood vessels, thereby starving the tumor of nutrients. PARP inhibitors, another targeted therapy, block the enzyme poly(ADP-ribose) polymerase, which helps repair DNA damage in cancer cells, leading to cell death. Investigational agents like AMXI-5001 are being studied for their potential to treat advanced malignancies by targeting specific pathways involved in cancer cell survival and proliferation. Understanding these mechanisms is crucial for ovarian cancer patients as it helps in selecting the most effective treatment strategy based on the tumor's characteristics and the patient's overall health.
Potential targets for ovarian clear cell carcinoma: a review of updates and future perspectives.

Find a Location

Who is running the clinical trial?

AtlasMedx, IncorporatedLead Sponsor
Pamela Munster, MDStudy DirectorAtlasMedx, Incorporated
13 Previous Clinical Trials
499 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
~5 spots leftby Jan 2025