A Study To Evaluate Safety, Tolerability And Preliminary Activity Of AGX101 In Participants With Advanced Solid Tumors

Study Overview

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

N/A

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

DRUG: AGX101

AGX101-001

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	Results Reporting Dates	Study Record Updates
First Submitted 2024-05-26	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-03-13
First Submitted that Met QC Criteria 2024-05-30	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-03-17
First Posted (ACTUAL) 2024-06-03	Results First Posted N/A	Last Verified 2025-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 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	DRUG: AGX101 Antibody Drug Conjugate
EXPERIMENTAL: 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 t	DRUG: AGX101 Antibody Drug Conjugate

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 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

DRUG: AGX101

Antibody Drug Conjugate

EXPERIMENTAL: 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 t

DRUG: AGX101

Antibody Drug Conjugate

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
Terminal elimination half life (PK)	Determination of the terminal elimination half-life (t½)	22 days following the first dose of AGX101 (Day 1 through Day 22)
AUC (PK)	Determination of the AUC in 1 dosing interval	22 days following the first dose of AGX101 (Day 1 through Day 22)
Cmax (PK)	Determination of the Cmax concentration over a dosing interval, systemic clearance, volume of distribution at steady-state (Vss), and accumulation ratio from first dose to steady-state	22 days following the first dose of AGX101 (Day 1 through Day 22)
Number of Participants with Antidrug Antibodies (ADA) to AGX101	Incidence and titers of ADA will be measured	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	Determination the objective response rate (ORR)	Approximately 6 months and up to 3 years
Efficacy as measured by Duration of Response (DoR) Assessed by Investigator	Determination of the duration of response (DoR)	Approximately 6 months and up to 3 years
Efficacy as measured by Disease Control Rate (DCR)	Determination of the disease control rate (DCR)	Approximately 6 months and up to 3 years
Efficacy as measured by Proportion of Participants with Progression Free Survival (PFS) According to RECIST v1.1 Evaluated by the Investigator	Determine progression-free survival (PFS)/PFS assessed per immune-related response evaluation criteria (iPFS).	Approximately 6 months and up to 3 years
Efficacy as measured by Duration of Treatment		Approximately 6 months and up to 3 years
Overall Survival		Approximately 6 months and up to 3 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Glen Weiss, MD

Phone Number: 857-203-7808

Email: trials@angiex.com

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:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Glen Weiss, MD, Medical Lead

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record