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

September 7, 2026 updated by: Angiex, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Recruiting
        • USC/Norris Comprehensive Cancer Center
        • Principal Investigator:
          • Diana Hanna, MD
    • Florida
      • Sarasota, Florida, United States, 34232
        • Recruiting
        • Florida Cancer Specialist
        • Principal Investigator:
          • Judy Wang, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Saiama Waqar, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Center
        • Principal Investigator:
          • Meredith P Pelster, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • UT MD Anderson
        • Contact:
        • Principal Investigator:
          • Michael Nakazawa
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • NEXT Oncology
        • Contact:
        • Principal Investigator:
          • Ismael Rodriguez Rivera, MD
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Recruiting
        • NEXT Oncology
        • Principal Investigator:
          • Alexander Spira, MD
        • Contact:
          • Blake Patterson
          • Phone Number: 703-783-4505

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Histologically confirmed unresectable, locally advanced, or metastatic solid tumors.
  • Refractory to or relapsed after all standard therapies known to provide proven clinical benefit, unless the patient is not a candidate for standard treatment, there is no standard treatment, or the patient refuses standard treatment after expressing an understanding of all available therapies with proven clinical benefit
  • Willing to authorize use of existing archival tissue, unless otherwise discussed with Sponsor
  • 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
  • Have adequate organ function
  • LVEF ≥ 50%, as determined on cardiac ECHO or cardiac multiple-gated acquisition (MUGA) scan
  • Highly effective contraception for both male and female patients throughout the study

Exclusion Criteria:

  • Colorectal cancer patients with an unresected primary colorectal tumor and non-small-cell lung cancer with predominant squamous histology (ie, squamous cell carcinoma of the lung) are excluded unless otherwise discussed and approved by Sponsor
  • Clinically unstable central nervous system (CNS) tumors or brain metastasis (stable and/or asymptomatic CNS metastases allowed)
  • Have not recovered to ≤ Grade 1 or baseline from all AEs due to previous therapies (patients with ≤ Grade 2 neuropathy, endocrine-related irAEs, or other AEs may be eligible after discussion with the Sponsor)
  • Has an active vasculitis that has required systemic treatment in the past 2 years prior to starting study treatment
  • Significant (ie, ≥ Grade 2) ocular disturbances
  • Variceal bleeding within 6 months prior to treatment, currently untreated or incompletely treated varices with bleeding, or who otherwise are at a high risk of bleeding
  • Any other concurrent antineoplastic treatment except for allowed local radiation of lesions for palliation (to be considered non-target lesions after treatment) and hormone ablation
  • Uncontrolled or life-threatening symptomatic concomitant disease, including known symptomatic HIV positive with an AIDS defining opportunistic infection within the last year, known symptomatic active hepatitis B or C, or known active tuberculosis
  • Has undergone a major surgery within 3 weeks prior to starting study treatment or has inadequate healing or recovery from complications of surgery prior to starting study treatment
  • Has received prior radiotherapy within 2 weeks prior to starting study treatment
  • 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
  • Patients on a potent CYP3A inhibitor or CPY3A inducer who cannot be changed to another medication
  • Has an active infection requiring concurrent systemic antibiotic therapy
  • A woman of child-bearing potential (WOCBP) who has a positive pregnancy test prior to treatment
  • Is breastfeeding or expecting to conceive or father children within the projected duration of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Expansion Phase
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.
Drug: AGX101
Antibody Drug Conjugate
Other Names:
  • ADC
Experimental: Dose Escalation Phase
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.
Drug: AGX101
Antibody Drug Conjugate
Other Names:
  • ADC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptable maximum tolerated dose for participants
Time Frame: 21 days following the first dose of AGX101 (Day 1 through Day 21)
Maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of AGX101 will be characterized
21 days following the first dose of AGX101 (Day 1 through Day 21)
Number of participants with adverse events
Time Frame: Screening through end of treatment, approximately 6 months and up to 3 years
Evaluation of the incidence, severity, and duration of adverse events
Screening through end of treatment, approximately 6 months and up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Terminal elimination half life (PK)
Time Frame: 22 days following the first dose of AGX101 (Day 1 through Day 22)
Determination of the terminal elimination half-life (t½)
22 days following the first dose of AGX101 (Day 1 through Day 22)
AUC (PK)
Time Frame: 22 days following the first dose of AGX101 (Day 1 through Day 22)
Determination of the AUC in 1 dosing interval
22 days following the first dose of AGX101 (Day 1 through Day 22)
Cmax (PK)
Time Frame: 22 days following the first dose of AGX101 (Day 1 through Day 22)
Determination of the Cmax concentration over a dosing interval, systemic clearance, volume of distribution at steady-state (Vss), and accumulation ratio from first dose to steady-state
22 days following the first dose of AGX101 (Day 1 through Day 22)
Number of Participants with Antidrug Antibodies (ADA) to AGX101
Time Frame: Approximately 6 months and up to 3 years
Incidence and titers of ADA will be measured
Approximately 6 months and up to 3 years
Efficacy as measured by Proportion of Participants with Objective Response Rate (ORR) According to RECIST v1.1 Evaluated by the Investigator
Time Frame: Approximately 6 months and up to 3 years
Determination the objective response rate (ORR)
Approximately 6 months and up to 3 years
Efficacy as measured by Duration of Response (DoR) Assessed by Investigator
Time Frame: Approximately 6 months and up to 3 years
Determination of the duration of response (DoR)
Approximately 6 months and up to 3 years
Efficacy as measured by Disease Control Rate (DCR)
Time Frame: Approximately 6 months and up to 3 years
Determination of the disease control rate (DCR)
Approximately 6 months and up to 3 years
Efficacy as measured by Proportion of Participants with Progression Free Survival (PFS) According to RECIST v1.1 Evaluated by the Investigator
Time Frame: Approximately 6 months and up to 3 years
Determine progression-free survival (PFS)/PFS assessed per immune-related response evaluation criteria (iPFS).
Approximately 6 months and up to 3 years
Efficacy as measured by Duration of Treatment
Time Frame: Approximately 6 months and up to 3 years
Approximately 6 months and up to 3 years
Overall Survival
Time Frame: Approximately 6 months and up to 3 years
Approximately 6 months and up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Angiex, Inc.

Investigators

  • Study Director: Glen Weiss, MD, Medical Lead

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2024

Primary Completion (Estimated)

March 6, 2027

Study Completion (Estimated)

September 6, 2027

Study Registration Dates

First Submitted

May 26, 2024

First Submitted That Met QC Criteria

May 30, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

September 9, 2026

Last Update Submitted That Met QC Criteria

September 7, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGX101-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe