Trials / Recruiting
RecruitingNCT06440005
A Study to Evaluate Safety, Tolerability and Preliminary Activity of AGX101 in Participants With Advanced Solid Tumors
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Angiex, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AGX101 | Antibody Drug Conjugate |
Timeline
- Start date
- 2024-07-22
- Primary completion
- 2026-09-06
- Completion
- 2027-09-06
- First posted
- 2024-06-03
- Last updated
- 2026-02-11
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06440005. Inclusion in this directory is not an endorsement.