A Study of AGX101 for Advanced Solid Tumors
This study is testing a new treatment called AGX101 for people with advanced solid tumors (cancers that form solid masses). AGX101 is an antibody-drug conjugate (ADC), which means it's designed to deliver a drug directly to cancer cells. The main goals of this study are to find a safe dose of AGX101 and to see if it causes any side effects. We also want to see if AGX101 shows any early signs of helping to treat the cancer. You might be able to join if you have advanced solid tumors that have not responded to standard treatments, or if standard treatments are not an option for you. The study plans to enroll 80 participants. The current recruitment status is unclear.
- Study design
- This study is testing AGX101 in 80 participants with advanced solid tumors. The phase of the study is not specified.
- What's involved
- AGX101 will be given through a vein (intravenously) every 3, 6, or 9 weeks. You may continue treatment until your disease gets worse, side effects are too severe, or you decide to stop.
- Compensation
- Not stated in the trial record.
- Follow-up
- After your last dose of AGX101, you will have an end-of-treatment visit and two safety follow-up phone calls for up to 90 days.
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NCT06440005
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
Recruiting
PHASE1Ages 18+InterventionalTreatmentAngiex, Inc.
~80 participants
Updated 2026-02-11 on ClinicalTrials.gov
What's tested:AGX101
At a glance
Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acceptable maximum tolerated dose for participants
Measured over 21 days following the first dose of AGX101 (Day 1 through Day 21)
+1 more outcome measured
Conditions
Where it's being run
6 sites across 6 statesCalifornia1
Florida1
Missouri1
Tennessee1
Texas1
Virginia1
Study leadership
- Glen Weiss, MD · STUDY_DIRECTOR · Medical Lead
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
What this trial measures
- Acceptable maximum tolerated dose for participants21 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
- Number of participants with adverse eventsScreening through end of treatment, approximately 6 months and up to 3 years
Evaluation of the incidence, severity, and duration of adverse events