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NCT06364410 · ClinicalTrials.gov registry record · Phase 1

Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors

A Phase 1 study of Metastatic Malignant Solid Neoplasm and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 1
Development phase
48
Enrollment target
1
Study location

NCT06364410: Recruiting Phase 1 study of Metastatic Malignant Solid Neoplasm and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, sponsored by National Cancer Institute (NCI).

NCT06364410 is a Phase 1 study of Metastatic Malignant Solid Neoplasm and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 48 participants, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06364410, a Phase 1 study of Metastatic Malignant Solid Neoplasm and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 1
Development phase
48 participants
Enrollment target
1
Study location

Study Summary

This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive and cyclin E amplified gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue or lymph nodes (locally advanced), that have spread from where it first started (primary site) to other places in the body (metastatic), or that cannot be removed by surgery (unresectable). Azenosertib is in a class of medications called kinase inhibitors. It inhibits a protein called Wee1. Inhibition of the Wee1 protein can make tumor cells more vulnerable to chemotherapy drugs, leading to tumor cell death. Trastuzumab deruxtecan is in a class of medications called antibody-drug conjugates. It is composed of a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called deruxtecan. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers deruxtecan to kill them. Giving azenosertib in combination with trastuzumab deruxtecan may be safe, tolerable, and/or more effective in treating patients with locally advanced, metastatic, or unresectable HER2-positive gastric, gastroesophageal junction, or other solid tumors, compared to just trastuzumab deruxtecan alone.

Primary Outcome

A Bayesian optimal interval design will be used to determine the maximum tolerated dose of the T-DXd (DS-8201a) and azenosertib (ZN-c3) combination.

Conditions Studied

Metastatic Malignant Solid Neoplasm Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 Clinical Stage IV Gastric Cancer AJCC v8 Clinical Stage III Gastric Cancer AJCC v8 Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 Locally Advanced Malignant Solid Neoplasm Metastatic Gastroesophageal Junction Adenocarcinoma Metastatic Gastric Carcinoma Locally Advanced Gastroesophageal Junction Adenocarcinoma Locally Advanced Gastric Carcinoma

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy Procedure
  • PROCEDURE Echocardiography Test
  • DRUG Azenosertib

Study Locations (1)

Texas

  • M D Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2025-02-03
Est. Completion 2027-07-08
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What NCT06364410 shows while recruiting

NCT06364410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 206-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (77% lower).

The record links to 10 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT06364410 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT06364410 about?

NCT06364410 is a clinical study titled "Testing the Combination of the Anticancer Drugs Trastuzumab Deruxtecan (DS-8201a) and Azenosertib (ZN-c3) in Patients With Stomach or Other Solid Tumors". This phase I trial tests the safety, side effects, and best dose of azenosertib in combination with trastuzumab deruxtecan in treating patients with HER2-positive and cyclin E amplified gastric or gastroesophageal junction cancer and other HER2-positive solid tumors that have spread to nearby tissue...

What is the current status of trial NCT06364410?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2025-02-03. Estimated completion is 2027-07-08.

What conditions does trial NCT06364410 study?

This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8.

What interventions are being tested in trial NCT06364410?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), Echocardiography Test (PROCEDURE), Azenosertib (DRUG).

Who is sponsoring clinical trial NCT06364410?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06364410 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Metastatic Malignant Solid Neoplasm

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06364410's enrollment target sits among peer trials

48 57th of 92 higher than 36 of 92 other Metastatic Malignant Solid Neoplasm trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06364410

Source: ClinicalTrials.gov NCT06364410, the US trial registry maintained by the National Library of Medicine. NCT06364410 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.