RECRUITING

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

Conditions

Cancer Advanced Cancer Locally Advanced Carcinoma Metastatic Solid Tumor Breast Cancer Prostate Cancer Colorectal Cancer Pancreatic Cancer Liver Cancer Angiosarcoma Solid Tumor ADC Antibody Drug Conjugate AGX101

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

Official Title

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

Quick Facts

Study Start:2024-07-22

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06440005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* Colorectal cancer patients with unresected colorectal tumors 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

Inclusion Criteria

Exclusion 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

* Colorectal cancer patients with unresected colorectal tumors 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

Contacts and Locations

Study Contact

Glen Weiss, MD

CONTACT

857-203-7808

trials@angiex.com

Principal Investigator

Glen Weiss, MD

STUDY_DIRECTOR

Medical Lead

Study Locations (Sites)

Sarah Cannon Research Center

Nashville, Tennessee, 37203

United States

NEXT Oncology

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Angiex, Inc.

Glen Weiss, MD, STUDY_DIRECTOR, Medical Lead

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-22

Study Completion Date2027-07

Study Record Updates

Study Start Date2024-07-22

Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

ADC
Antibody Drug Conjugate
AGX101

Additional Relevant MeSH Terms

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