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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product and does not imply any judgment about causality. Events meeting the definition of an AE include: * Any abnormal laboratory test results (hematology, serum chemistry, or urinalysis) or other safety assessments (e.g., ECGs, vital signs measurements), including those that worsen from baseline, and

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
Guangzhou Sinogen Pharmaceutical Co.

1 total trials

What NCT05038150 shows while recruiting

NCT05038150 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 193-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (64% lower).

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 lists 8 locations in 8 states (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.

Learn More About Clinical Trials

Similar trials for Advanced Solid Tumor

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 NCT05038150's enrollment target sits among peer trials

70 142nd of 189 higher than 42 of 189 other Advanced Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Advanced Solid Tumor 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 NCT05038150

Source: ClinicalTrials.gov NCT05038150, the US trial registry maintained by the National Library of Medicine. NCT05038150 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.