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NCT05038150 · ClinicalTrials.gov registry record · Phase 1

Study of SGN1 in Patients With Advanced Solid Tumor

A Phase 1 study of Advanced Solid Tumor, sponsored by Guangzhou Sinogen Pharmaceutical Co..

Recruiting
Registry status
Phase 1
Development phase
70
Enrollment target
8
Study locations

NCT05038150 is a Phase 1 study of Advanced Solid Tumor that is actively recruiting participants, run by Guangzhou Sinogen Pharmaceutical Co.. The registered enrollment target is 70 participants, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (64% lower). The trial reports 8 study locations across 8 states.

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The verdict

NCT05038150, a Phase 1 study of Advanced Solid Tumor, is actively recruiting participants, sponsored by Guangzhou Sinogen Pharmaceutical Co..

RECRUITING
Registry status
Phase 1
Development phase
70 participants
Enrollment target
8
Study locations

Study Summary

Objectives:To assess the safety and tolerability followed by a dose expansion study to characterize safety, and preliminary efficacy of SGN1 in participants with refractory solid tumors. Study Rationale:The mechanism of action for SGN1 is based on the fact that most tumors are methionine dependent. SGN1 is designed to be used as a tumor therapeutic bacterium that can preferentially replicate and accumulate in tumors and starve them of essential amino acids by delivering the oncolytic enzyme L-Methioninase. Patient Population:The treatment populations shall be patients presenting with histologically confirmed advanced and/or metastatic solid tumors that are refractory to standard therapy and for which no other conventional therapy exists.

Conditions Studied

Advanced Solid Tumor

Interventions

  • DRUG SGN1

Study Locations (8)

Arizona

  • Banner MD Anderson Cancer Center - Gilbert

California

  • Health Chao Family Comprehensive Cancer Center - Orange

Michigan

  • Barbara Ann Karmanos Cancer Hospital dba Karmanos Cancer Center - Detroit

Ohio

  • University of Cincinnati Cancer Center - Cincinnati

Guangdong

  • Guangdong Clifford Hospital - Guangzhou

Heilongjiang

  • Harbin Medical University Cancer Hospital - Harbin

Shanghai Municipality

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital - Shanghai

Sichuan

  • West China Hospital of Sichuan University - Chengdu

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2023-01-16
Est. Completion 2028-08-31
Phase Phase 1

Sponsor

Guangzhou Sinogen Pharmaceutical Co.

1 total trials

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What the Registry Record Tells You About NCT05038150

The ClinicalTrials.gov registry entry for NCT05038150 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (64% lower). The listed sponsor is Guangzhou Sinogen Pharmaceutical Co., which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which SGN1 is the first listed.

NCT05038150 reports 8 study locations spanning 8 distinct geographic areas - top geographies include Arizona, California, Michigan.

Frequently Asked Questions

What is clinical trial NCT05038150 about?

NCT05038150 is a clinical study titled "Study of SGN1 in Patients With Advanced Solid Tumor". Objectives:To assess the safety and tolerability followed by a dose expansion study to characterize safety, and preliminary efficacy of SGN1 in participants with refractory solid tumors. Study Rationale:The mechanism of action for SGN1 is based on the fact that most tumors are methionine dependent....

What is the current status of trial NCT05038150?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2023-01-16. Estimated completion is 2028-08-31.

What conditions does trial NCT05038150 study?

This clinical trial studies the following conditions: Advanced Solid Tumor.

What interventions are being tested in trial NCT05038150?

The interventions under investigation include: SGN1 (DRUG).

Who is sponsoring clinical trial NCT05038150?

This trial is sponsored by Guangzhou Sinogen Pharmaceutical Co., which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05038150 being conducted?

This trial has 8 study locations across Arizona, California, Michigan, Ohio, Guangdong. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.