A Phase 1/2 interventional study of AVZO-103 and Combination Agent in Solid Tumor Cancer, Locally Advanced and Metastatic Solid Tumors, sponsored by Avenzo Therapeutics, Inc.. Recruiting at 14 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Avenzo Therapeutics, Inc. · Phase 1/2, Interventional, and Treatment
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.
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.
Key Inclusion Criteria:
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).
Key Exclusion Criteria:
Part A
Drug: AVZO-103
Part B
Drug: AVZO-103 · Drug: Combination Agent
Part A
Drug: AVZO-103
Part B
Drug: AVZO-103 · Drug: Combination Agent
Specific dose in protocol specified schedule
Per label based on combination agent used
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.
Time frame: Approximately 2 years
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)
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.
Time frame: From baseline through disease progression or study completion (approximately 2 years)
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)
Defined as the time from the first confirmed response to radiologic/objective progression.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
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Avenzo Therapeutics, Inc.