Trial NCT07193511
BEACON-1: Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other Solid Tumors (AVZO-103-1001)
- Phase
- Phase 1/2
- Sponsor
- Avenzo Therapeutics, Inc.
- Conditions
- Solid Tumor Cancer; Locally Advanced; Metastatic Solid Tumors; Urothelial Cancer
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Key Inclusion Criteria:
* Patient must be an adult, 18 years of age and older with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1Performance status 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.Brain metastases 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.Cardiac
* 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.
Restrictions found (3)
- Brain metastasesOutrightexclusionShow in the text
- CardiacConditionalexclusionShow in the text
- Performance statusConditionalinclusion
ECOG ≤ 1
Show in the text
Recruiting in Massachusetts
- Avenzo Therapeutics Recruiting Site · Boston, Suffolk County