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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

No Placebo-Only Group

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.

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.

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

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I have waited the required time after my last cancer treatment before joining this trial.

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I am fully active or can carry out light work.

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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:

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

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I have a serious heart condition.

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I am currently taking antibiotics for an infection.

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I have been treated for vasculitis in the last 2 years.

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I have moderate to severe vision problems.

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I have had bleeding from varices in the last 6 months or have untreated varices at high risk of bleeding.

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I am taking a strong medication that affects liver enzymes and cannot switch.

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I had radiotherapy less than 2 weeks ago.

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I do not have any severe illnesses like uncontrolled HIV, hepatitis B or C, or active tuberculosis.

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I haven't had major surgery in the last 3 weeks or still recovering from one.

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I am a woman who can have children and my pregnancy test before treatment was positive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 6 months and up to 3 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptable maximum tolerated dose for participants

Number of participants with adverse events

Secondary study objectives

AUC (PK)

Cmax (PK)

Efficacy as measured by Disease Control Rate (DCR)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 14Eligibility criteria met