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
clinicaltrials.gov
Phase
Phase 1/Phase 2
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
355
clinicaltrials.gov
Lead sponsor
Avenzo Therapeutics, Inc.
clinicaltrials.gov
Start date
2025-10-02
clinicaltrials.gov
Number of sites
14
clinicaltrials.gov

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.
clinicaltrials.gov
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)
clinicaltrials.gov
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
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 1/Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2030-09-01
clinicaltrials.gov
First posted
2025-09-26
clinicaltrials.gov
Registry last updated
2026-08-25
clinicaltrials.gov
Primary completion date
2030-03-01
clinicaltrials.gov
Start date
2025-10-02
clinicaltrials.gov

Participants
355
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
355
clinicaltrials.gov
Protocol amendments
0
clinicaltrials.gov
Number of sites
14
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Avenzo Therapeutics, Inc.
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07193511
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07193511
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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.

  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
clinicaltrials.gov

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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)