Evaluating AGX101 for advanced solid tumors

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

This study is testing a new drug called AGX101 to see if it can help people with advanced solid tumors who haven't had success with other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Angiex, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 6 sites (Los Angeles, California and 5 other locations)
• Trial ID: NCT06440005 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and preliminary activity of AGX101, an antibody-drug conjugate, in patients with advanced solid tumors. Participants will receive AGX101 intravenously at varying dose levels, with treatment repeated every 3, 6, or 9 weeks until disease progression or unacceptable toxicity occurs. The study aims to gather data on the drug's effects in a diverse population of patients who have not responded to standard therapies.

Who should consider this trial

Good fit: Ideal candidates include individuals with histologically confirmed unresectable, locally advanced, or metastatic solid tumors who have exhausted standard treatment options.

Not a fit: Patients who have not been diagnosed with advanced solid tumors or those who are candidates for standard therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment choices.

How similar studies have performed: Other studies involving antibody-drug conjugates have shown promise, indicating potential for success with this novel approach.

Eligibility criteria

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

Where this trial is running

Los Angeles, California and 5 other locations

• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States (Recruiting)
• Florida Cancer Specialist — Sarasota, Florida, United States (Recruiting)
• Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
• Sarah Cannon Research Center — Nashville, Tennessee, United States (Recruiting)
• NEXT Oncology — San Antonio, Texas, United States (Recruiting)
• NEXT Oncology — Fairfax, Virginia, United States (Recruiting)

Study contacts

• Study coordinator: Glen Weiss, MD

Conditions Cancer; Advanced Cancer; Locally Advanced Carcinoma; Metastatic Solid Tumor; Breast Cancer; Prostate Cancer; Colorectal Cancer; Pancreatic Cancer