AVZO-103 for Bladder Cancer

(AVZO-103-1001 Trial)

Recruiting at 3 trial locations

Overseen By Medical Information

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Avenzo Therapeutics, Inc.

Must not be taking: Steroids, IV antibiotics

Disqualifiers: CNS metastases, Cardiovascular condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

355 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AVZO-103 for individuals with advanced bladder cancer and other solid tumors. Researchers aim to assess the treatment's safety, tolerability, and effects on the body, both alone and with other therapies. Participants should have advanced bladder cancer or another solid tumor and must provide specific test results and samples for the study. The trial includes different groups to compare the treatment's effectiveness alone and in combination with other therapies. As a Phase 1 trial, this research focuses on understanding how AVZO-103 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that AVZO-103 is likely to be safe for humans?

Research shows that AVZO-103 is being tested for safety in people with bladder cancer and other solid tumors. This marks the first human trial of AVZO-103, so no previous safety data exists. However, the FDA has approved the drug for testing, indicating it has passed the initial safety checks required to begin clinical trials. This approval suggests that early tests indicate potential safety for humans. The trial's first phase will focus on understanding how well participants tolerate the treatment and what side effects may occur. Although safety data is still being collected from this trial, the FDA's approval to test the drug provides some reassurance about its initial safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for bladder cancer?

Unlike the standard treatments for bladder cancer, which often include chemotherapy or immunotherapy, AVZO-103 is unique because it targets specific cancer pathways at a molecular level. This novel mechanism of action may offer more precise targeting of cancer cells, potentially leading to fewer side effects. Researchers are particularly excited about AVZO-103 because it can be used both as a monotherapy and in combination with other treatments, providing flexible options for different stages of the disease. This adaptability could enhance treatment effectiveness and improve patient outcomes.

What evidence suggests that AVZO-103 might be an effective treatment for bladder cancer?

Currently, no direct evidence exists on AVZO-103's effectiveness for bladder cancer, as this is the first clinical trial for the drug. However, the FDA has approved testing AVZO-103 in patients with solid tumors, indicating promise in earlier lab studies. This trial tests AVZO-103 in separate treatment arms: one as monotherapy and another in combination with other treatments. The main goal is to understand how the drug acts in the body and its potential to fight tumors. This early research is crucial to determine if AVZO-103 could become a future treatment option for bladder cancer. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for patients with advanced or metastatic urothelial cancer or other solid tumors. Details on specific inclusion and exclusion criteria are not provided, but typically participants must have a certain stage of disease and meet health standards.

Inclusion Criteria

My cancer is advanced and confirmed by tests.

Measurable disease as assessed by Investigator using RECIST v1.1

Other protocol-defined Inclusion criteria apply

Exclusion Criteria

Prior Stevens-Johnson syndrome/toxic epidermal necrolysis

History of drug-induced interstitial lung disease (ILD)

Other protocol-defined Exclusion criteria apply

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation

Assessment of safety, tolerability, and determination of maximum tolerated dose (MTD) and preliminary recommended Phase 2 dose (RP2D) of AVZO-103 as a monotherapy

Approximately 2 years

Phase 2: Dose Expansion

Assessment of antitumor activity of AVZO-103 as a monotherapy and in combination therapy

Approximately 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 76 months

What Are the Treatments Tested in This Trial?

Interventions

• AVZO-103

Trial Overview The study tests AVZO-103 alone and combined with other drugs in people with serious bladder cancers or tumors. It's looking at safety, how the body reacts to it, the highest dose without bad effects, and if it shrinks tumors.

How Is the Trial Designed?

Group I: Phase 2, monotherapy Experimental Treatment 1 Intervention

Part A

Group II: Phase 2, combination Experimental Treatment 2 Interventions

Part B

Group III: Phase 1, monotherapy Experimental Treatment 1 Intervention

Part A

Group IV: Phase 1, combination Experimental Treatment 2 Interventions

Part B

Who Is Running the Clinical Trial?

Avenzo Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

430+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07193511

Study of AVZO-103 as a Single Agent and in Combination ... This study, the first clinical trial of AVZO-103, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and ...

2. bcan.org bcan.org/clinicaltrials/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/

Study of AVZO-103 as a Single Agent and in Combination ... This study, the first clinical trial of AVZO-103, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and ...

3. withpower.com withpower.com/trial/phase-2-neoplasm-metastasis-9-2025-5bdf4

AVZO-103 for Bladder Cancer This study, the first clinical trial of AVZO-103, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and ...

4. cancernetwork.com cancernetwork.com/view/in-the-news-top-fda-meetings-decisions-and-actions-in-cancer-care

In the News: Top FDA Meetings, Decisions, and Actions ... Bladder Cancer ... The FDA has given clearance to a new drug application of AVZO-103 (formerly VAC-103) for patients with solid tumors.

5. urotoday.com urotoday.com/conference-highlights/esmo-2025/esmo-2025-bladder-cancer/164052-esmo-2025-ev-103-cohort-k-efficacy-and-safety-of-enfortumab-vedotin-with-or-without-pembrolizumab-in-cisplatin-ineligible-patients-with-previously-untreated-locally-advanced-or-metastatic-urothelial-cancer-with-a-median-follow-up-of-3-5-years.html

ESMO 2025: EV-103 Cohort K: Efficacy and Safety ... After 5 years of follow-up in the Dose Escalation/Cohort A, EV+P continued to show durable responses and a meaningful survival, with a median OS ...

6. delta.larvol.com delta.larvol.com/Products/?ProductId=89b7c38b-305d-4d4d-97d2-7609736ab7d9

AVZO-103 / VelaVigo, Avenzo Therap AVZO-103-1001: Study of AVZO-103 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Urothelial Cancer or Other ...