AGX101 for Cancer

Recruiting at 2 trial locations

Overseen By Glen Weiss, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Angiex, Inc.

Must not be taking: CYP3A inhibitors, CYP3A inducers

Disqualifiers: Colorectal cancer, CNS tumors, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effects of AGX101, a new antibody-drug conjugate, on patients with advanced cancers that form tumors. The goal is to find the right dose that balances effectiveness and safety. Participants will receive AGX101 through an IV every 3, 6, or 9 weeks. This trial is open to individuals with advanced solid tumors who have not responded to other treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications for the AGX101 trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on a potent CYP3A inhibitor or inducer and cannot switch to another medication. There are also specific time requirements since your last cancer treatment, such as a minimum of 2 weeks for most chemotherapy and 3 weeks for biologic therapy.

Is there any evidence suggesting that AGX101 is likely to be safe for humans?

Research has shown that AGX101 is still under study to assess its safety in humans. As it is in early testing, it has not yet been proven safe or effective for treating cancer. The study's main goal is to determine how well people can tolerate it at different doses.

Results from earlier studies on AGX101 have focused on identifying any serious side effects. These studies represent the first step in evaluating how the body reacts to the drug. Scientists are examining any dose-related issues and their potential effects on people. Due to the trial's early stage, information about side effects remains limited.

AGX101 targets tumor cells with the aim of destroying them. However, as the drug is new, researchers are still learning about its safety. This trial will help determine the optimal dose that people can tolerate without significant problems. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

AGX101 is unique because it offers a new approach to treating cancer, specifically advanced angiosarcoma. Unlike traditional chemotherapy, which targets all rapidly dividing cells, AGX101 is designed to selectively target cancer cells, potentially reducing harmful side effects. This treatment uses an innovative infusion schedule that may enhance its effectiveness and improve patient outcomes. Researchers are excited about AGX101's potential to provide a more targeted and patient-friendly option compared to existing therapies.

What evidence suggests that AGX101 might be an effective treatment for cancer?

Research shows that AGX101 combines an antibody with a drug to target TM4SF1, a protein present in many cancers. Early lab studies demonstrated that AGX101 can work effectively without causing significant side effects when administered at the right doses. These studies found no major negative effects at effective doses. The trial includes a Dose Escalation Phase and a Dose Expansion Phase to further evaluate AGX101's safety and efficacy in humans. Although information from human studies remains limited, these early findings are encouraging for AGX101's potential in cancer treatment. ^{3 4 6 7 8}

Who Is on the Research Team?

Glen Weiss, MD

Principal Investigator

Medical Lead

Are You a Good Fit for This Trial?

This trial is for individuals with advanced solid tumors, such as various types of breast cancer and pancreatic cancer. Participants should have a tumor that has not responded to standard treatments or has returned after treatment.

Inclusion Criteria

LVEF ≥ 50%, as determined on cardiac ECHO or cardiac multiple-gated acquisition (MUGA) scan

My organs are working well.

Willing to authorize use of existing archival tissue, unless otherwise discussed with Sponsor

Exclusion Criteria

I haven't had a severe cancer needing treatment in the last 3 years.

I have a serious heart condition.

I am currently taking antibiotics for an infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

AGX-101 is administered in escalating doses to determine the maximum tolerated dose

21 days

Visits on Day 1 of every 3, 6, or 9-week cycle

Dose Expansion

AGX-101 is administered at a selected dose to a specific cancer type

Approximately 6 months and up to 3 years

Visits on Day 1 of every 3, 6, or 9-week cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 90 days following the last dose

End of treatment visit and two safety follow-up telephone contacts

What Are the Treatments Tested in This Trial?

Interventions

• AGX101

Trial Overview AGX101, an antibody-drug conjugate (ADC) designed to target and kill cancer cells, is being tested. Patients will receive AGX101 through an IV every three weeks until their disease progresses, they experience severe side effects, or choose to leave the study.

How Is the Trial Designed?

Group I: Dose Expansion Phase Experimental Treatment 1 Intervention

AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose expansion will be carried out with a selected dose and selected cancer type.

Group II: Dose Escalation Phase Experimental Treatment 1 Intervention

AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose escalation will be carried out in sequential cohorts of escalating doses, with an expansion cohort in advanced angiosarcoma.

Who Is Running the Clinical Trial?

Angiex, Inc.

Lead Sponsor

Trials

1

Recruited

80+

Published Research Related to This Trial

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]

Immunotherapies, particularly anti-PD-1 checkpoint inhibitors like nivolumab and pembrolizumab, have significantly improved survival rates for metastatic melanoma patients while being less toxic than traditional treatments.

Despite their better tolerability, anti-PD-1 therapies can still cause a range of immune-related adverse events, most of which are mild, but there is a pressing need to understand and manage severe side effects due to the increased life expectancy of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety of anti PD-1 therapeutics for the treatment of melanoma. Ramelyte, E., Schindler, SA., Dummer, R.[2018]

Targeted therapies for non-small cell lung cancer (NSCLC) have significantly improved treatment options, but their effectiveness can be compromised by issues like poor patient adherence and adverse events.

The review highlights the need for standardized monitoring protocols for the various toxicities associated with these therapies, which can include skin, gastrointestinal, lung, and heart-related side effects, to ensure better patient management and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Toxicities: Protocols for Monitoring the Adverse Events of Targeted Therapies Used in the Treatment of Non-Small Cell Lung Cancer. Hines, JB., Bowar, B., Levine, E., et al.[2023]

A meta-analysis of 53 Phase II/III/IV trials involving nearly 20,000 patients revealed that molecular target anticancer drugs significantly increase the risk of serious adverse events (SAEs) by 57% and fatal adverse events (FAEs) by 51% compared to placebo.

The overall incidence rates for SAEs and FAEs were found to be 26.9% and 2.3%, respectively, highlighting the need for careful monitoring and preventive measures for patients receiving these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis. Wang, Z., Yang, X., Wang, J., et al.[2020]

In a meta-analysis of 4413 patients from 8 randomized controlled trials, PD-1/PD-L1 inhibitors showed a significantly lower risk of all-grade adverse events (66.20% vs. 86.08%) and high-grade adverse events (14.26% vs. 43.53%) compared to chemotherapy, indicating a better safety profile.

While PD-1/PD-L1 inhibitors are generally safer, they are associated with a unique set of immune-related adverse events (irAEs) that can be severe, such as pneumonitis and thyroid dysfunction, which clinicians need to monitor closely to manage patient quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of PD-1/PD-L1 inhibitors in the treatment of non-small cell lung cancer: a meta-analysis of randomized controlled trials. Luo, W., Wang, Z., Tian, P., et al.[2021]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.4_suppl.829

AGX101: A TM4SF1-directed tubulin inhibitor conjugate in ... Conclusions: AGX101, targeting the TM4SF1 antigen, represents a promising new approach in cancer therapy. The preclinical data suggest that ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06440005

NCT06440005 | A Study to Evaluate Safety, Tolerability ... The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population.

3. clinicaltrialsarena.com clinicaltrialsarena.com/news/angiex-patient-cancers-agx101/

Angiex doses first patient in Phase I trial for solid cancers ... Preclinical results have shown positive results for AGX101, with a broad therapeutic window and no adverse signs at effective doses.

4. aacrjournals.org aacrjournals.org/cancerres/article/84/22_Supplement/C047/749927/Abstract-C047-AGX101-Preclinical-evaluation-of-a

AGX101: Preclinical evaluation of a TM4SF1-directed tubulin ... Conclusion: AGX101, targeting the TM4SF1 antigen, represents a promising new approach in cancer therapy. The preclinical data suggest that ...

5. angiex.com angiex.com/news/first-patient-dosed

Angiex Announces First Patient Dosed in Phase 1 Clinical ... We believe AGX101 has potential to help clinical cancer patients, especially in indications with high unmet need. We are excited to announce ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-safety-tolerability-and-preliminary-activity-of-agx101-in-participants-with-adv

A Study to Evaluate Safety, Tolerability and Preliminary ... The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient ...

7. angiex.com angiex.com/about-agx101

About AGX101 AGX101's payload is toxic to dividing cells, and is intended to kill cells in the tumor. TM4SF1 has several features that make it attractive as a cancer target.

8. angiex.com angiex.com/clinical-trial-q-a

Clinical Trial Q&A AGX101 is an experimental drug which is in a Phase 1 clinical trial. It has not been proven safe or effective, and much remains to be learned about its optimal ...