← Back to Search

Monoclonal Antibodies

AGX101 for Cancer

Phase 1
Recruiting
Research Sponsored by Angiex, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Time since the last dose of prior therapy to treat underlying malignancy (including other investigational therapy): Systemic cytotoxic chemotherapy: ≥ the duration of the most recent cycle of the previous regimen (with a minimum of 2 weeks for all, except 6 weeks for systemic nitrosourea or systemic mitomycin-C); Biologic therapy (eg, antibodies): ≥ 3 weeks; Small molecule therapies: ≥ 5 × half-life
Have an ECOG performance status of 0 to 1
Must not have
Has or had a potentially life-threatening second malignancy requiring systemic treatment within the last 3 years, or which would impede evaluation of treatment response
Clinically significant cardiovascular disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6 months and up to 3 years
Awards & highlights

Summary

This trial is testing a new treatment called AGX101 for cancer tumors. The study will look at how safe and effective AGX101 is at different doses in patients with advanced solid cancers. AGX

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects of AGX101 may include reactions at the infusion site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems. Specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have waited the required time after my last cancer treatment before joining this trial.
Select...
I am fully active or can carry out light work.
Select...
My cancer is advanced and cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't had a severe cancer needing treatment in the last 3 years.
Select...
I have a serious heart condition.
Select...
I am currently taking antibiotics for an infection.
Select...
I have been treated for vasculitis in the last 2 years.
Select...
I have moderate to severe vision problems.
Select...
I have had bleeding from varices in the last 6 months or have untreated varices at high risk of bleeding.
Select...
I am taking a strong medication that affects liver enzymes and cannot switch.
Select...
I had radiotherapy less than 2 weeks ago.
Select...
I do not have any severe illnesses like uncontrolled HIV, hepatitis B or C, or active tuberculosis.
Select...
I haven't had major surgery in the last 3 weeks or still recovering from one.
Select...
I am a woman who can have children and my pregnancy test before treatment was positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 months and up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 months and up to 3 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
Acceptable maximum tolerated dose for participants
Number of participants with adverse events
Secondary outcome measures
AUC (PK)
Cmax (PK)
Efficacy as measured by Disease Control Rate (DCR)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose Expansion PhaseExperimental Treatment1 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-week cycle in Dose Escalation Phase. Dose expansion will be carried out with a selected dose and selected cancer type.
Group II: Dose Escalation PhaseExperimental Treatment1 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-week cycle in Dose Escalation Phase. Dose escalation will be carried out in sequential cohorts of escalating doses.

Find a Location

Who is running the clinical trial?

Angiex, Inc.Lead Sponsor
Glen Weiss, MDStudy DirectorMedical Lead
5 Previous Clinical Trials
220 Total Patients Enrolled
~53 spots leftby May 2025