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)

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 to 75 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

27 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

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-1418 as a Single Agent and in Combination Therapy in Patients With Locally Advanced or Metastatic Solid Tumors

Conditions

Solid Tumor Cancer, Locally Advanced, Metastatic Solid Tumors, Lung Cancers, Epithelial Tumor, Biliary Tract Cancer (BTC)

Being tested

AVZO-1418, Combination Agent 1, Combination Agent 2

Keywords

Solid Tumors, Metastatic, Locally Advanced, Lung Cancer, Epithelial Solid Tumors, Biliary Tract Cancer, Urothelial Cancer, SCLC, HER3, EGFR, BTC, Small Cell Lung Cancer, NSCLC

Medical subject headings

Lung Neoplasms, Carcinoma, Biliary Tract Neoplasms, Nasopharyngeal Neoplasms, Neoplasm Metastasis, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• AVZO-1418Drug

  Specific dose in protocol specified schedule

• Combination Agent 1Drug

  Per label based on combination agent used

• Combination Agent 2Drug

  Per label based on combination agent used

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: Approximately 2 years

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

   Measured: Approximately 16 months

3. 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)

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.

   Measured: From baseline through disease progression 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.

1. First posted26 Jun 2025
2. Study start4 Jun 2025
3. Primary completionJun 2030 (estimated)
4. Study completionDec 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.