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

NCT06440005 | Recruiting Phase 1 FDA Drug

• 1 other identifier: AGX101-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 6

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

Keywords

ADC; Antibody Drug Conjugate; AGX101

Outcome Measures

Primary Outcomes (2)

• Acceptable maximum tolerated dose for participants

  Maximum tolerated dose (MTD) and the dose-limiting toxicities (DLTs) of AGX101 will be characterized

  21 days following the first dose of AGX101 (Day 1 through Day 21)

• Number of participants with adverse events

  Evaluation of the incidence, severity, and duration of adverse events

  Screening through end of treatment, approximately 6 months and up to 3 years

Secondary Outcomes (10)

• Terminal elimination half life (PK)

  22 days following the first dose of AGX101 (Day 1 through Day 22)

• AUC (PK)

  22 days following the first dose of AGX101 (Day 1 through Day 22)

• Cmax (PK)

  22 days following the first dose of AGX101 (Day 1 through Day 22)

• Number of Participants with Antidrug Antibodies (ADA) to AGX101

  Approximately 6 months and up to 3 years

• Efficacy as measured by Proportion of Participants with Objective Response Rate (ORR) According to RECIST v1.1 Evaluated by the Investigator

  Approximately 6 months and up to 3 years

Study Arms (2)

Dose Escalation Phase

EXPERIMENTAL

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.

Drug: AGX101

Dose Expansion Phase

EXPERIMENTAL

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.

Drug: AGX101

Interventions

AGX101 DRUG

Antibody Drug Conjugate

Also known as: ADC

Dose Escalation Phase; Dose Expansion Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Angiex, Inc.: lead

Study Sites (6)

USC/Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

Florida Cancer Specialist

Sarasota, Florida, 34232, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Sarah Cannon Research Center

Nashville, Tennessee, 37203, United States

RECRUITING

NEXT Oncology

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Oncology

Fairfax, Virginia, 22031, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms; Neoplasm Metastasis; Breast Neoplasms; Prostatic Neoplasms; Colorectal Neoplasms; Pancreatic Neoplasms; Liver Neoplasms; Hemangiosarcoma

Condition Hierarchy (Ancestors)

Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Liver Diseases; Sarcoma; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms, Vascular Tissue

Study Officials

• Glen Weiss, MD

  Medical Lead

  STUDY DIRECTOR

Central Study Contacts

Glen Weiss, MD

CONTACT

857-203-7808; trials@angiex.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A mTPI-2 design (Guo et al, 2017) with a target DLT rate of at most 30% will be applied for dose-escalation and expansion to determine the AGX101 RP2D.

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: June 3, 2024
• Study Start: July 22, 2024
• Primary Completion (Estimated): September 6, 2026
• Study Completion (Estimated): September 6, 2027
• Last Updated: February 11, 2026

Record last verified: 2026-02

Locations

US (6)