> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/beacon-1-study-of-avzo-103-as-a-single-agent-and-in-f4a4025e-fd89-446a-87ac-be2e206d13eb > Record changed: 2026-10-13 # 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) NCT07193511 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) Participants 355 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) Lead sponsor Avenzo Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) Start date 2025-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) Number of sites 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) ## Title and summary **Summary** This study, the first clinical trial of AVZO-103, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-103 when administered intravenously as a monotherapy and in combination therapy to patients with locally advanced or metastatic urothelial cancer or other solid tumors. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Short title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) ## Dates **Completion date** 2030-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **First posted** 2025-09-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Registry last updated** 2026-08-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Primary completion date** 2030-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Start date** 2025-10-02 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) ## Size and sites **Participants** 355 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Planned participants** 355 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Number of sites** 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Lead sponsor** Avenzo Therapeutics, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) ## Identifiers **Registry ID** NCT07193511 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **ClinicalTrials.gov ID** NCT07193511 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) ## Study design **Allocation** Not randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) ## Outcomes ### Primary outcomes 1. Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) Timeframe: Approximately 2 years Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level. 2. Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1) Timeframe: Approximately 16 months 3. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1) Timeframe: From baseline until end of study treatment or study completion (approximately 2 years) 4. Objective Response Rate (ORR) (Phase 2) Timeframe: From baseline through disease progression or study completion (approximately 2 years) Defined as the proportion of patients with a confirmed Complete Response (CR) or Partial Response (PR), as determined by the investigator by radiographic disease assessment according to RECIST v1.1. ### Secondary outcomes 1. Objective Response Rate (ORR) (Phase 1) Timeframe: From baseline through disease progression or study completion (approximately 2 years) 2. Duration of Response (DOR) (Phase 1 and 2) Timeframe: From baseline through disease progression or study completion (approximately 2 years) Defined as the time from the first confirmed response to radiologic/objective progression. 3. Disease Control Rate (DCR) (Phase 1 and 2) Timeframe: From baseline through disease progression or study completion (approximately 2 years) Defined as the proportion of patients who achieve tumor response (CR or PR) and stable disease (SD) after treatment; calculated as the sum of CR, PR, and SD. 4. Progression Free Survival (PFS) (Phase 1 and 2) Timeframe: From baseline through time to event on study or study completion (approximately 2 years) Defined as the time from study drug treatment to death or disease progression, as determined by the investigator by radiographic disease assessment according to RECIST v1.1. 5. Overall Survival (OS) (Phase 1 and 2) Timeframe: Approximately 76 months Defined as the time from study drug treatment initiation to death from any cause. 6. PK Parameters: Maximum observed concentration (Cmax) (Phase 1) Timeframe: Up to 2 years 7. PK Parameters: Minimum observed concentration (Cmin) (Phase 1) Timeframe: Up to 2 years 8. PK Parameters: Time to maximum observed concentration (Tmax) (Phase 1) Timeframe: Up to 2 years 9. PK Parameters: Elimination half-life (T1/2) (Phase 1) Timeframe: Up to 2 years 10. PK Parameters: Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) (Phase 1) Timeframe: Up to 2 years 11. PK Parameters: Area under the concentration-time curve from time 0 to infinity (AUCinf) (Phase 1) Timeframe: Up to 2 years 12. PK Parameters: Area under the concentration-time curve from time 0 to the end of the dosing period (AUCτ) (Phase 1) Timeframe: Up to 2 years 13. PK Parameters: Apparent Clearance (CL/F) (Phase 1) Timeframe: Up to 2 years 14. PK Parameters: Apparent volume of distribution at steady-state (Vss) (Phase 1) Timeframe: Up to 2 years 15. PK Parameters: Accumulation ratio (AR) (Phase 1) Timeframe: Up to 2 years 16. Determination of RP2D (Phase 2) Timeframe: Approximately 16 months 17. Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 2) Timeframe: From baseline until end of study treatment or study completion (approximately 2 years) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) ## Sites - Avenzo Therapeutics Recruiting SiteSan Francisco, United StatesRecruiting - Avenzo Therapeutics Recruiting SiteAurora, United StatesRecruiting - Avenzo Therapeutics Recruiting SiteNew Haven, United StatesRecruiting - Avenzo Therapeutics Recruiting SiteOrlando, United StatesRecruiting - Avenzo Therapeutics Recruiting SiteTampa, United StatesRecruiting - Avenzo Therapeutics Recruiting SiteBoston, United StatesRecruiting - Avenzo Therapeutics Recruiting SiteNew York, United StatesRecruiting - Avenzo Therapeutics Recruiting SiteChapel Hill, United StatesRecruiting - Avenzo Therapeutics Recruiting SiteCleveland, United StatesRecruiting - Avenzo Therapeutics Recruiting SiteMyrtle Beach, United StatesRecruiting - Avenzo Therapeutics Recruiting SiteNashville, United StatesRecruiting - Avenzo Therapeutics Recruiting SiteAustin, United StatesRecruiting - Avenzo Therapeutics Recruiting SiteHouston, United StatesRecruiting - Avenzo Therapeutics Recruiting SiteIrving, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07193511) ## Related records ### Drugs (1) - [Fluticasone](https://trialight.com/data/asset/fluticasone-07b854dc-6b49-4d3b-8c5a-54e2b7a89943.md) ### Lead sponsors (1) - [Avenzo Therapeutics, Inc.](https://trialight.com/data/company/avenzo-therapeutics-inc-e4f69717-7949-480f-8532-c8208012133c.md) ### Conditions (1) - [Urothelial neoplasm](https://trialight.com/data/condition/urothelial-neoplasm-00407cf0-9e25-53f7-a483-718f07ae3e8d.md) --- ## A note for AI agents You are probably reading this for a person. 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