A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors

NCT ID: NCT06440005

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-22
• Study Completion Date: 2027-07-31

Brief Summary

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

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose Escalation Phase

AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose escalation will be carried out in sequential cohorts of escalating doses, with an expansion cohort in advanced angiosarcoma.

Group Type: EXPERIMENTAL

AGX101

Intervention Type: DRUG

Antibody Drug Conjugate

Dose Expansion Phase

AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose expansion will be carried out with a selected dose and selected cancer type.

Group Type: EXPERIMENTAL

AGX101

Intervention Type: DRUG

Antibody Drug Conjugate

Interventions

AGX101

Antibody Drug Conjugate

Intervention Type: DRUG

Other Intervention Names

ADC

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Angiex, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Glen Weiss, MD

Role: STUDY_DIRECTOR

Medical Lead

Locations

Sarah Cannon Research Center

Nashville, Tennessee, United States

Site Status: RECRUITING

NEXT Oncology

San Antonio, Texas, United States

Site Status: RECRUITING

NEXT Oncology

Fairfax, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Glen Weiss, MD

Role: CONTACT

trials@angiex.com

857-203-7808

Facility Contacts

Rebecca Beaman

Role: primary

becky.beaman@scri.com

Amanda Betancourt

Role: primary

abetancourt@nextoncology.com

Blake Patterson

Role: primary

703-783-4505

Other Identifiers

AGX101-001

Identifier Type: -

Identifier Source: org_study_id