Solid Tumor CancerPhase 1/2NCT07193511
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)
A Phase 1/2 study testing AVZO-103 and Combination Agent in people with Solid Tumor Cancer and Locally Advanced, run by Avenzo Therapeutics, Inc. at 15 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancer, Locally Advanced, Metastatic Solid Tumors
- What is being tested?
- AVZO-103 and Combination Agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 355 participants
- Where
- 15 sitesUnited States
- Study dates
- 2 Oct 2025to Sep 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
Avenzo Therapeutics Recruiting Site
Aurora, Colorado, 80045
- Recruiting
Avenzo Therapeutics Recruiting Site
Austin, Texas, 78758
- Recruiting
Avenzo Therapeutics Recruiting Site
Boston, Massachusetts, 02114
- Recruiting
Avenzo Therapeutics Recruiting Site
Chapel Hill, North Carolina, 27514
- Recruiting
Avenzo Therapeutics Recruiting Site
Cleveland, Ohio, 44106
- Recruiting
Avenzo Therapeutics Recruiting Site
Houston, Texas, 77030
- Recruiting
Avenzo Therapeutics Recruiting Site
Irving, Texas, 75039
- Recruiting
Avenzo Therapeutics Recruiting Site
Myrtle Beach, South Carolina, 29572
- Recruiting
Avenzo Therapeutics Recruiting Site
Nashville, Tennessee, 37203
- Recruiting
Avenzo Therapeutics Recruiting Site
New Haven, Connecticut, 06519
- Recruiting
Avenzo Therapeutics Recruiting Site
New York, New York, 10065
- Recruiting
Avenzo Therapeutics Recruiting Site
Oklahoma City, Oklahoma, 73104
- Recruiting
Avenzo Therapeutics Recruiting Site
Orlando, Florida, 32827
- Recruiting
Avenzo Therapeutics Recruiting Site
San Francisco, California, 94158
- Recruiting
Avenzo Therapeutics Recruiting Site
Tampa, Florida, 33612
About this study
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
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.
Read the detailed description
Phase 1 is a dose escalation phase which will assess the safety and tolerability of AVZO-103 and determine the maximum tolerated dose (MTD) and preliminary recommended Phase 2 dose (RP2D) of AVZO-103 as a monotherapy. This data can guide selection of combination schedules and agents.
Phase 2 is a dose expansion phase that will aim to assess the antitumor activity of AVZO-103 as a monotherapy and in combination therapy.
- Being tested
- AVZO-103, Combination Agent
- Keywords
- Solid Tumors, Metastatic, Locally Advanced, Urothelial Cancer
- Medical subject headings
- Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVZO-103Drug
Specific dose in protocol specified schedule
Combination AgentDrug
Per label based on combination agent used
| Study group | Role | What they receive |
|---|---|---|
| Phase 1, monotherapy | Experimental | Part A Receives: Drug: AVZO-103 |
| Phase 1, combination | Experimental | Part B Receives: Drug: AVZO-103; Drug: Combination Agent |
| Phase 2, monotherapy | Experimental | Part A Receives: Drug: AVZO-103 |
| Phase 2, combination | Experimental | Part B Receives: Drug: AVZO-103; Drug: Combination Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)
Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level.
Measured: Approximately 2 years
Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1)
Measured: Approximately 16 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)
Measured: From baseline until end of study treatment or study completion (approximately 2 years)
Objective Response Rate (ORR) (Phase 2)
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.
Measured: From baseline through disease progression or study completion (approximately 2 years)
Secondary outcomes (17)
Objective Response Rate (ORR) (Phase 1)
Measured: From baseline through disease progression or study completion (approximately 2 years)
Duration of Response (DOR) (Phase 1 and 2)
Defined as the time from the first confirmed response to radiologic/objective progression.
Measured: From baseline through disease progression or study completion (approximately 2 years)
Disease Control Rate (DCR) (Phase 1 and 2)
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.
Measured: From baseline through disease progression or study completion (approximately 2 years)
Progression Free Survival (PFS) (Phase 1 and 2)
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.
Measured: From baseline through time to event on study or study completion (approximately 2 years)
Overall Survival (OS) (Phase 1 and 2)
Defined as the time from study drug treatment initiation to death from any cause.
Measured: Approximately 76 months
PK Parameters: Maximum observed concentration (Cmax) (Phase 1)
Measured: Up to 2 years
PK Parameters: Minimum observed concentration (Cmin) (Phase 1)
Measured: Up to 2 years
PK Parameters: Time to maximum observed concentration (Tmax) (Phase 1)
Measured: Up to 2 years
PK Parameters: Elimination half-life (T1/2) (Phase 1)
Measured: Up to 2 years
PK Parameters: Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) (Phase 1)
Measured: Up to 2 years
PK Parameters: Area under the concentration-time curve from time 0 to infinity (AUCinf) (Phase 1)
Measured: Up to 2 years
PK Parameters: Area under the concentration-time curve from time 0 to the end of the dosing period (AUCτ) (Phase 1)
Measured: Up to 2 years
PK Parameters: Apparent Clearance (CL/F) (Phase 1)
Measured: Up to 2 years
PK Parameters: Apparent volume of distribution at steady-state (Vss) (Phase 1)
Measured: Up to 2 years
PK Parameters: Accumulation ratio (AR) (Phase 1)
Measured: Up to 2 years
Determination of RP2D (Phase 2)
Measured: Approximately 16 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 2)
Measured: From baseline until end of study treatment or study completion (approximately 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start2 Oct 2025
- Primary completionMar 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 355 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Avenzo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07193511
- Sponsor's protocol ID
- AVZO-103-1001
- Status last verified
- Nov 2025
- First submitted
- 24 Sep 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 ID
- NCT07193511
- Acronym / sponsor ID
- AVZO-103-1001
- Keywords
- Solid Tumors, Metastatic, Locally Advanced, Urothelial Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 355 participants (estimated)
- Lead sponsor
- Avenzo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Phase 1 is a dose escalation phase which will assess the safety and tolerability of AVZO-103 and determine the maximum tolerated dose (MTD) and preliminary recommended Phase 2 dose (RP2D) of AVZO-103 as a monotherapy. This data can guide selection of combination schedules and agents.
Phase 2 is a dose expansion phase that will aim to assess the antitumor activity of AVZO-103 as a monotherapy and in combination therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Phase 1, monotherapy | Experimental | Drug: AVZO-103Part A |
| Phase 1, combination | Experimental | Drug: AVZO-103, Drug: Combination AgentPart B |
| Phase 2, monotherapy | Experimental | Drug: AVZO-103Part A |
| Phase 2, combination | Experimental | Drug: AVZO-103, Drug: Combination AgentPart B |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVZO-103Specific dose in protocol specified schedule | Drug | Phase 1, combination, Phase 1, monotherapy, Phase 2, combination, Phase 2, monotherapy |
| Combination AgentPer label based on combination agent used | Drug | Phase 1, combination, Phase 2, combination |
Primary outcome
Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1)
Time frame: Approximately 2 years
Number of participants with DLTs assessed for severity using CTCAE v5.0 criteria will be summarized by dose level.
Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1)
Time frame: Approximately 16 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1)
Time frame: From baseline until end of study treatment or study completion (approximately 2 years)
Objective Response Rate (ORR) (Phase 2)
Time frame: 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.
17 secondary outcomes
Objective Response Rate (ORR) (Phase 1)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
Duration of Response (DOR) (Phase 1 and 2)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
Disease Control Rate (DCR) (Phase 1 and 2)
Time frame: From baseline through disease progression or study completion (approximately 2 years)
Progression Free Survival (PFS) (Phase 1 and 2)
Time frame: From baseline through time to event on study or study completion (approximately 2 years)
Overall Survival (OS) (Phase 1 and 2)
Time frame: Approximately 76 months
PK Parameters: Maximum observed concentration (Cmax) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Minimum observed concentration (Cmin) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Time to maximum observed concentration (Tmax) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Elimination half-life (T1/2) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Area under the concentration-time curve from time 0 to infinity (AUCinf) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Area under the concentration-time curve from time 0 to the end of the dosing period (AUCτ) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Apparent Clearance (CL/F) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Apparent volume of distribution at steady-state (Vss) (Phase 1)
Time frame: Up to 2 years
PK Parameters: Accumulation ratio (AR) (Phase 1)
Time frame: Up to 2 years
Determination of RP2D (Phase 2)
Time frame: Approximately 16 months
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 2)
Time frame: From baseline until end of study treatment or study completion (approximately 2 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AVZO-103 and Combination Agent in people with Solid Tumor Cancer and Locally Advanced, run by Avenzo Therapeutics, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Medical Information ((858) 239-2944, ClinicalTrials@avenzotx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1) (time frame: Approximately 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.