AVZO-103 alone and with other treatments for advanced urothelial and other solid tumors
A Phase 1/2, First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of AVZO-103, a Nectin4/Trop2 ADC, as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors
This trial will test intravenous AVZO-103, alone and combined with other cancer drugs, to see if it is safe and helps adults with locally advanced or metastatic urothelial cancer or other solid tumors.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 355 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Avenzo Therapeutics, Inc. Industry-sponsored |
| Locations | 9 sites (Orlando, Florida and 8 other locations) |
| Trial ID | NCT07193511 on ClinicalTrials.gov |
What this trial studies
This first-in-human Phase 1/2 program gives AVZO-103 intravenously as monotherapy and in combination to adults with locally advanced or metastatic urothelial carcinoma and selected other solid tumors. Phase 1 uses dose escalation to characterize safety, tolerability, pharmacokinetics/pharmacodynamics, and to determine the maximum tolerated dose and a preliminary recommended Phase 2 dose. Phase 2 expands selected dose cohorts to measure antitumor activity using RECIST v1.1 and further define safety and PK. Participants must have measurable disease, ECOG performance status ≤1, provide molecular test results and tumor tissue, and are excluded if they have active untreated CNS metastases.
Who should consider this trial
Good fit: Adults (≥18 years) with histologically confirmed locally advanced or metastatic urothelial cancer or other eligible solid tumors, measurable disease by RECIST v1.1, ECOG performance status ≤1, life expectancy >3 months, and willingness to provide molecular test results and tumor tissue are the intended participants.
Not a fit: Patients with active, untreated central nervous system metastases, poor performance status, or non-measurable disease are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, AVZO-103 could provide a new treatment option that controls tumor growth for some patients with advanced urothelial or other solid tumors.
How similar studies have performed: AVZO-103 is untested in humans (this is the first clinical trial), although other targeted and combination therapies have shown benefit in urothelial and various solid tumors.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Patient must be an adult, 18 years of age and older with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of \> 3 months. * Patients with histologically or cytologically confirmed locally advanced/metastatic malignancies for tumor types of preferred indications: o Locally advanced or metastatic urothelial cancer and other solid tumors (as specified in the protocol). * Measurable disease as assessed by Investigator using RECIST v1.1. * Agree to provide molecular test report results to confirm eligibility and archival tumor samples and/or fresh biopsy, as applicable. * Other protocol-defined Inclusion criteria apply. Key Exclusion Criteria: * Patients with active central nervous system (CNS) metastases are not eligible. Patients with asymptomatic and treated brain metastases may participate if they are radiologically stable for at least 4 weeks prior to the first dose of this study and do not require steroid treatment. Patients with suspected or confirmed leptomeningeal disease are not eligible, even if treated. * Prior Stevens-Johnson syndrome/toxic epidermal necrolysis. * History of drug-induced interstitial lung disease (ILD). * History of any serious cardiovascular condition. * Infection requiring IV antibiotics, antivirals, or antifungals within 2 weeks prior to first dose. * History of allogenic stem cell or solid organ transplant. * Other protocol-defined Exclusion criteria apply.
Where this trial is running
Orlando, Florida and 8 other locations
- Avenzo Therapeutics Recruiting Site — Orlando, Florida, United States (Recruiting)
- Avenzo Therapeutics Recruiting Site — Tampa, Florida, United States (Recruiting)
- Avenzo Therapeutics Recruiting Site — Boston, Massachusetts, United States (Recruiting)
- Avenzo Therapeutics Recruiting Site — New York, New York, United States (Recruiting)
- Avenzo Therapeutics Recruiting Site — Chapel Hill, North Carolina, United States (Recruiting)
- Avenzo Therapeutics Recruiting Site — Myrtle Beach, South Carolina, United States (Recruiting)
- Avenzo Therapeutics Recruiting Site — Nashville, Tennessee, United States (Recruiting)
- Avenzo Therapeutics Recruiting Site — Austin, Texas, United States (Recruiting)
- Avenzo Therapeutics Recruiting Site — Irving, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Medical Information
- Email: ClinicalTrials@avenzotx.com
- Phone: (858) 239-2944
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.