Tests AGX101 in adults with advanced solid tumors
Tests the safety of AGX101, a targeted drug, in adults with advanced solid cancers.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
Key facts
- Where
- Fairfax, Houston, Los Angeles, Nashville, San Antonio, Sarasota, and St Louis, United StatesSee the 7 sites
- Phase
- Phase 1
Where in United States
- NEXT OncologyFairfax, United StatesTaking people
- UT MD AndersonHouston, United StatesTaking people
- USC / Norris Comprehensive Cancer CenterLos Angeles, United StatesTaking people
- Sarah Cannon Research CenterNashville, United StatesTaking people
- NEXT OncologySan Antonio, United StatesTaking people
- Florida Cancer SpecialistSarasota, United StatesTaking people
- Washington University School of MedicineSt Louis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Angiex, Inc.
- Trial code
- NCT06440005
- Record updated
- 9 September 2026
- Original description
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.Read full original descriptionShow less
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.
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: 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; 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; 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; 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; 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; Clinically unstable central nervous system (CNS) tumors or brain metastasis (stable and/or asymptomatic CNS metastases allowed); Significant (ie, ≥ Grade 2) ocular disturbances; Is breastfeeding or expecting to conceive or father children within the projected duration of the study.