Actively Recruiting
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
Led by Angiex, Inc. · Updated on 2026-02-11
80
Participants Needed
6
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AGX101, an antibody-drug conjugate therapy, in people with advanced solid tumors including unresectable, locally advanced, or metastatic cancers. The study aims to learn about the safety, tolerability, and preliminary activity of AGX101 at different dose levels. This is a Phase 1, open-label, dose-escalation and expansion study involving participants with various solid tumors who have exhausted standard treatment options or for whom standard treatments are not suitable. AGX101 will be given by intravenous infusion starting with a 90-minute infusion, followed by a 60-minute infusion, and then subsequent 30-minute infusions on Day 1 of cycles repeated every 3, 6, or 9 weeks. The study includes a dose-escalation phase where doses are increased in groups of participants, followed by a dose-expansion phase focusing on a selected dose and cancer type. Participants may continue treatment until their disease progresses, unacceptable side effects occur, or they choose to stop. Participants will attend treatment visits according to the dosing schedule and have an end of treatment visit. Safety follow-up will be conducted via two telephone contacts up to 90 days after the last dose. Researchers will monitor adverse events, dosing tolerance, and treatment effects over approximately 6 months and up to 3 years. They will also assess pharmacokinetics, immune response to the drug, and measures of cancer response and survival during this period.
CONDITIONS
Brief Title
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed unresectable, locally advanced, or metastatic solid tumors
- Refractory to or relapsed after all standard therapies known to provide clinical benefit, or not candidate for standard treatment
- Willing to authorize use of existing archival tissue unless otherwise discussed
- Time since last dose of prior therapy: at least duration of most recent cycle (minimum 2 weeks for most, 6 weeks for nitrosourea or mitomycin-C; 3 weeks for biologics; 5 half-lives for small molecules)
- ECOG performance status of 0 to 1
- Adequate organ function
- Left ventricular ejection fraction (LVEF) of 50% or higher
- Use of highly effective contraception during the study for both males and females
You will not qualify if you...
- Colorectal cancer patients with unresected primary tumor and non-small-cell lung cancer with squamous histology unless approved by Sponsor
- Clinically unstable CNS tumors or brain metastases (stable/asymptomatic allowed)
- Not recovered to Grade 1 or baseline from prior therapy adverse events
- Active vasculitis requiring systemic treatment in past 2 years
- Significant ocular disturbances (Grade 2 or higher)
- Recent variceal bleeding or untreated varices at high risk of bleeding
- Concurrent antineoplastic treatments except allowed local radiation and hormone ablation
- Uncontrolled or life-threatening diseases including symptomatic HIV, hepatitis B or C, active tuberculosis
- Major surgery within 3 weeks or inadequate surgical recovery
- Prior radiotherapy within 2 weeks
- Life-threatening second malignancy within past 3 years
- Clinically significant cardiovascular disease
- Use of potent CYP3A inhibitors or inducers that cannot be changed
- Active infection requiring systemic antibiotics
- Positive pregnancy test or breastfeeding
- Expecting to conceive or father children during study duration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months and up to 3 years
Participants receive AGX101 infusions on Day 1 of every 3, 6, or 9-week cycle in dose escalation or expansion phases.
Infusions on Day 1 of every 3, 6, or 9-week cycle
Duration - Up to 3 years
Participants are monitored for safety, adverse events, and treatment efficacy after completing treatment.
Visits as scheduled for safety and efficacy assessments
Trial Site Locations
Total: 6 locations
1
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
Florida Cancer Specialist
Sarasota, Florida, United States, 34232
Actively Recruiting
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
4
Sarah Cannon Research Center
Nashville, Tennessee, United States, 37203
Actively Recruiting
5
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
6
NEXT Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
Research Team
G
Glen Weiss, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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