Actively Recruiting
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
Led by Angiex, Inc. · Updated on 2026-02-11
80
Participants Needed
6
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Cancer that is refractory to or has relapsed after all standard therapies known to provide clinical benefit, or patient is not a candidate for or refuses standard treatment after understanding available options
- Willingness to authorize use of existing archival tissue samples
- Adequate time since last dose of prior therapy: at least the duration of the most recent chemotherapy cycle (minimum 2 weeks, 6 weeks for certain drugs), 3 weeks for biologic therapy, or 5 times the half-life for small molecule therapies
- ECOG performance status of 0 to 1
- Adequate organ function
- Left ventricular ejection fraction (LVEF) of 50% or higher by cardiac ECHO or MUGA scan
- Use of highly effective contraception for both male and female patients throughout the study
You will not qualify if you...
- Patients with colorectal cancer with unresected primary tumor or non-small-cell lung cancer with squamous cell carcinoma histology, unless approved by Sponsor
- Clinically unstable central nervous system tumors or brain metastases (stable or asymptomatic allowed)
- Not recovered to Grade 1 or baseline from adverse events due to previous therapies (exceptions may apply after Sponsor discussion)
- Active vasculitis requiring systemic treatment within the past 2 years
- Significant ocular disturbances of Grade 2 or higher
- Variceal bleeding within 6 months prior to treatment or untreated/incompletely treated varices with bleeding risk
- Concurrent antineoplastic treatments other than allowed local radiation and hormone ablation
- Uncontrolled or life-threatening symptomatic diseases including active HIV with recent opportunistic infection, active hepatitis B or C, or active tuberculosis
- Major surgery within 3 weeks before starting treatment or inadequate healing
- Prior radiotherapy within 2 weeks before starting treatment
- Life-threatening second malignancy requiring systemic treatment within 3 years or impeding evaluation
- Clinically significant cardiovascular disease
- Use of potent CYP3A inhibitors or inducers that cannot be changed
- Active infection requiring systemic antibiotic therapy
- Women with positive pregnancy test prior to treatment
- Breastfeeding or planning to conceive or father children during the study
AI-Screening
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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
CONTACT
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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