Recruiting
Phase 1

AGX101

Sponsor:

Angiex, Inc.

Code:

NCT06440005

Conditions

Cancer

Advanced Cancer

Locally Advanced Carcinoma

Metastatic Solid Tumor

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AGX101

Study Details

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

Study ID

NCT06440005

Start date

Jul 22, 2024

Status verified date

Feb, 2026

Completion date

Sep 6, 2027

Anticipated

Primary completion date

Sep 6, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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 an expansion cohort in advanced angiosarcoma.

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 type.

Interventions

AGX101

Antibody Drug Conjugate

Primary outcome measure

  • Acceptable maximum tolerated dose for participants [ Time Frame: 21 days following the first dose of AGX101 (Day 1 through Day 21) ]
  • Number of participants with adverse events [ Time Frame: Screening through end of treatment, approximately 6 months and up to 3 years ]

Central Contacts and Locations

Central contacts

Glen Weiss, MD

857-203-7808trials@angiex.com

Locations

USC/Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Principal Investigator:

Diana Hanna, MD

Florida Cancer Specialist

Recruiting

Sarasota, Florida, United States, 34232

Contacts

Nancy Olsen

941-377-9993nolsen@flcancer.com

Principal Investigator:

Judy Wang, MD

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Sara Mitchum

314-273-8602saram@wustl.edu

Principal Investigator:

Saiama Waqar, MD

Sarah Cannon Research Center

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Rebecca Beaman

becky.beaman@scri.com

Principal Investigator:

Meredith P Pelster, MD

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Amanda Betancourt

abetancourt@nextoncology.com

Principal Investigator:

Ismael Rodriguez Rivera, MD

NEXT Oncology

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Blake Patterson

703-783-4505

Principal Investigator:

Alexander Spira, MD

More Information

Sponsor

Angiex, Inc.

Last update posted

Feb 11, 2026

Last verified

Feb, 2026

Keywords

  • ADC
  • Antibody Drug Conjugate
  • AGX101

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Angiex, Inc. on 2026-02-11.