← Back to Search

Protein Tyrosine Phosphatase Inhibitor

ET0038 for Advanced Cancer (FIRST Trial)

Phase 1

Waitlist Available

Research Sponsored by Etern BioPharma (Shanghai) Co., Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 2 years

Awards & highlights

FIRST Trial Summary

This trial is testing a new drug, ET0038, to see if it's safe and effective in treating advanced solid tumors.

Who is the study for?

This trial is for adults with advanced solid tumors who have tried standard treatments without success, or can't tolerate them, or if no standard options exist. They must be able to swallow pills and not have major health issues like active infections, uncontrolled brain metastasis, recent surgeries, certain eye problems, or a history of severe bleeding disorders.Check my eligibility

What is being tested?

The study tests ET0038, an oral medication taken daily in 21-day cycles to see how safe it is and how well it works against various solid tumors. The first part of the trial will find the best dose by gradually increasing amounts given to new groups of patients.See study design

What are the potential side effects?

Potential side effects are not detailed here but may include typical reactions seen with cancer therapies such as nausea, fatigue, blood count changes and increased risk of infection due to immune system suppression.

FIRST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determination of Maximum Tolerated Dose (MTD) of ET0038

Number of participants with adverse events

Recommended Phase 2 Dose (RP2D)

Secondary outcome measures

Area under the curve

Cmax

Disease Control Rate

+6 more

Other outcome measures

Changes in phospho-ERK levels

NGS test of RTK/MAPK pathway genes

FIRST Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment1 Intervention

Oral capsules taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with ET0038 administered, once daily (QD).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Etern BioPharma (Shanghai) Co., LtdLead Sponsor

2 Previous Clinical Trials

74 Total Patients Enrolled

Media Library

ET0038 (Protein Tyrosine Phosphatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05525559 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has ET0038 been officially sanctioned by the FDA?

"As this is a Phase 1 trial, which typically involves limited information on safety and efficacy, the team at Power assigned ET0038 a score of one."

Answered by AI

What is the ultimate aim of this clinical trial?

"According to the principal investigator, Etern BioPharma (Shanghai) Co., Ltd, the primary purpose of this clinical trial will be ascertaining Recommended Phase 2 Dose (RP2D), and it is expected that results will be collected over a two-year period. Other metrics being observed include Tmax which marks Time of highest observed plasma concentration of ET0038, Area under the curve representing Area under the plasma concentration time curve for ET0038, and Cmax denoting Highest observed plasma concentration of ET0038."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SHP2 Inhibitor ET0038 Monotherapy in Patients With Advanced Solid Tumors

2022. "SHP2 Inhibitor ET0038 Monotherapy in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05525559.