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AVENTINE-1: Study of AVZO-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (AVZO-1418-1001)

ConditionsSolid Tumor CancerLocally AdvancedMetastatic Solid TumorsLung CancersEpithelial TumorBiliary Tract Cancer (BTC)Urothelial CancerNasopharyngeal Cancers
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAvenzo Therapeutics, Inc.

About this trial

This study, the first clinical trial of AVZO-1418, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of AVZO-1418 when administered intravenously as a monotherapy and potentially in combination therapy to patients with locally advanced or metastatic epithelial solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient must be an adult, between 18 and 75 years of age with an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1 and a life expectancy of > 3 months.

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.

Disqualifiers

Uncontrolled hypertension.

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.

History of drug-induced interstitial lung disease (ILD).

History of any serious cardiovascular condition.

Trial design

Design model

Sequential

Treatments tested in this trial

  • AVZO-1418

    Drug

    Specific dose in protocol specified schedule

  • Combination Agent 1

    Drug

    Per label based on combination agent used

  • Combination Agent 2

    Drug

    Per label based on combination agent used

Treatment groups

480 Participants
are divided into 4 treatment groups
Group A: Phase 1, monotherapyExperimental treatment 1 intervention
Group B: Phase 1, combinationExperimental treatment 3 interventions
Group C: Phase 2, monotherapyExperimental treatment 1 intervention
Group D: Phase 2, combinationExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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
2

Determine the maximum tolerated dose (MTD) and/or preliminary recommended Phase 2 dose (RP2D) (Phase 1)

Time frame
Approximately 16 months
3

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)
4

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)

Secondary outcomes

1

Objective Response Rate (ORR) (Phase 1)

Time frame
From baseline through disease progression or study completion (approximately 2 years)
2

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)
3

Disease Control Rate (DCR) (Phase 1 and 2)

Defined as the proportion of patients who achieve tumor relief (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)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Avenzo Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov
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