RecruitingPhase 1NCT06440005

A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors

A Phase 1, Open-Label, Dose-Escalation and Expansion Study of AGX101, a TM4SF1 Directed Antibody Drug Conjugate in Patients With Unresectable, Locally Advanced, or Metastatic Solid Tumors

Sponsor

Angiex, Inc.

Enrollment

80 participants

Start Date

Jul 22, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Prostate Cancer Metastatic Solid Tumor Cancer Advanced Cancer Locally Advanced Carcinoma

Summary

AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. 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. AGX101will be administered intravenously. Dosing of AGX101 will be repeated once every 3, 6 or 9 weeks. Participants may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal. Subjects will attend an end of treatment visit and will receive two safety follow-up telephone contacts up to 90 days following the last dose of study drug.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new cancer drug called AGX101 in people whose solid tumors (cancers in organs or tissues) have stopped responding to all other available treatments. The study starts with a small dose and gradually increases it to find the safest and most effective amount. **You may be eligible if...** - You have been confirmed to have an advanced, inoperable, or metastatic solid tumor - Your cancer has stopped responding to or has come back after all standard treatment options - You are in good enough health to tolerate an experimental treatment **You may NOT be eligible if...** - You have a blood cancer (like leukemia or lymphoma) - You have untreated or unstable cancer that has spread to the brain - You have serious heart, liver, kidney, or other organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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