AMXI-5001 for Advanced Cancers

Recruiting at8 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: AtlasMedx, Incorporated

Must not be taking: CYP3A4 inhibitors, inducers

Disqualifiers: Cancer treatment, Cardiovascular disease, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop using strong inhibitors or inducers of CYP3A4 (a liver enzyme) within 7 days before starting the study and throughout the trial. This includes some antibiotics, antifungals, anticonvulsants, and grapefruit. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

What safety data exists for AMXI-5001 in humans?

The safety data for AMXI-5001, which may be similar to other immune checkpoint inhibitors like anti-PD-1 and anti-PD-L1 drugs, shows that most side effects are mild and can be managed with steroids. However, some patients may experience more severe immune-related side effects, which require careful monitoring and management by healthcare professionals. ^{1 2 3 4 5}

Research Team

Pamela Munster, MD

Principal Investigator

AtlasMedx, Incorporated

Eligibility Criteria

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.

Inclusion Criteria

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

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

My cancer has worsened despite treatment.

Exclusion Criteria

I haven't taken any strong CYP3A4 affecting drugs or eaten grapefruit in the last week.

I do not have any major organ system diseases.

I do not have serious heart disease or abnormal heart tests.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of AMXI-5001 to determine the Maximum Tolerated Dose and Recommended Phase 2 Dose

12 months

Dose Expansion

Additional participants receive AMXI-5001 at the recommended dose to further characterize safety and efficacy

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Treatment Details

Interventions

• AMXI-5001 (Other)

Trial Overview 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.

Participant Groups

Group I: AMXI-5001 Treatment Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

AtlasMedx, Incorporated

Lead Sponsor

Trials

1

Recruited

120+

Findings from Research

Immune checkpoint antibodies targeting the PD-1/PD-L1 pathway have shown significant antitumor activity and have been approved for use as single-agent therapies in metastatic malignant melanoma and nonsmall-cell lung cancer.

Understanding the toxicities associated with PD-1/PD-L1 blockade and having effective management strategies is crucial for maximizing both the safety and efficacy of these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. Naidoo, J., Page, DB., Li, BT., et al.[2023]

Immune-related adverse events (irAEs) are common but mostly mild and manageable with steroids in patients receiving immune checkpoint inhibitors, highlighting the importance of effective management strategies as these therapies become more widely used.

The study outlines a comprehensive 3-pronged strategy for managing irAEs, including a dedicated Immune Wellness Clinic for monitoring at-risk patients, a repository for supporting research, and an Immunotoxicity Tumor Board for handling severe cases, which can enhance patient care and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimizing Care for Patients With Adverse Events From Immunotherapeutics. Sheehan, K., Price, C., Hafez, N.[2021]

Immune checkpoint inhibitors, such as those targeting CTLA-4, PD-1, and PD-L1, have become significant in cancer immunotherapy, showing promise in enhancing antitumor effects through both single-agent and combination therapies.

However, these therapies can lead to immune-related adverse events (irAEs), which vary in frequency and severity, highlighting the need for better understanding and management strategies for these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immune-Related Adverse Events From Immune Checkpoint Inhibitors. Marrone, KA., Ying, W., Naidoo, J.[2022]

In a meta-analysis of eight studies involving 597 patients with advanced hepatocellular carcinoma, immune checkpoint therapy was found to significantly increase the risk of adverse events (AEs), with a pooled incidence rate of 20.87 per 100 person-years for severe AEs.

The analysis revealed that the risk of severe AEs was correlated with the Child-Pugh classification, indicating that patients with more advanced liver disease may be at higher risk, while specific therapies like pembrolizumab showed a lower risk of severe AEs but a higher risk of fatal adverse events compared to others.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of adverse events in advanced hepatocellular carcinoma with immune checkpoint therapy: A systematic review and meta-analysis. Yuan, H., Mao, J., Liu, C., et al.[2021]

This study aims to create a comprehensive toxicity profile for anti-PD-1 and anti-PD-L1 drugs by analyzing systematic reviews and meta-analyses, focusing on treatment-related adverse events in cancer patients.

The research will utilize a network meta-analysis approach to synthesize data from various studies, ensuring a thorough understanding of the safety and adverse effects associated with these immunotherapy treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-PD-1 and anti-PD-L1 drugs treatment-related adverse events for patients with cancer: Protocol for an overview of systematic reviews with meta-analyses. Li, J., Liu, M., Wang, J., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Toxicities of the anti-PD-1 and anti-PD-L1 immune checkpoint antibodies. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Optimizing Care for Patients With Adverse Events From Immunotherapeutics. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Immune-Related Adverse Events From Immune Checkpoint Inhibitors. [2022]

4. France pubmed.ncbi.nlm.nih.gov

Risk of adverse events in advanced hepatocellular carcinoma with immune checkpoint therapy: A systematic review and meta-analysis. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Anti-PD-1 and anti-PD-L1 drugs treatment-related adverse events for patients with cancer: Protocol for an overview of systematic reviews with meta-analyses. [2023]