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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Angiex, Inc.
Study ID
NCT06440005
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AGX101 — DRUG
    Antibody Drug Conjugate

Study Details

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.

Key Dates

Start date
Jul 22, 2024
Status verified
Feb 2026
Primary completion
Sep 6, 2026
Completion
Sep 6, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Acceptable maximum tolerated dose for participants [ Time Frame: 21 days following the first dose of AGX101 (Day 1 through Day 21) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
USC/Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Diana Hanna, MD (PRINCIPAL_INVESTIGATOR)
Florida Cancer SpecialistSarasotaFlorida34232
Nancy Olsen
[email protected]
941-377-9993
Judy Wang, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Sara Mitchum
[email protected]
314-273-8602
Saiama Waqar, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research CenterNashvilleTennessee37203
Rebecca Beaman
[email protected]
Meredith P Pelster, MD (PRINCIPAL_INVESTIGATOR)
NEXT OncologySan AntonioTexas78229
Amanda Betancourt
[email protected]
Ismael Rodriguez Rivera, MD (PRINCIPAL_INVESTIGATOR)
NEXT OncologyFairfaxVirginia22031
Blake Patterson
703-783-4505
Alexander Spira, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By condition
Breast cancerColorectal cancerLiver cancerPancreatic cancerProstate cancer
By specialty
OncologyBreast oncologyWomen's healthGI oncologyHepatologyProstate oncologyMen's healthUrology
By research site
USC/Norris Comprehensive Cancer Center· Los Angeles, CAFlorida Cancer Specialist· Sarasota, FLWashington University School of Medicine· St Louis, MOSarah Cannon Research Center· Nashville, TNNEXT Oncology· San Antonio, TXNEXT Oncology· Fairfax, VA

Related Studies