ET0038 for Solid Tumors, Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
BUMC - Mary Crowley Cancer Research Centers (MCCRC), Dallas, TX
Solid Tumors, Advanced Solid Tumors+1 More
ET0038 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase I, open-label, multi-center, dose-finding study to assess the safety, pharmacokinetics, and preliminary efficacy of ET0038 in patients with advanced solid tumors. It is anticipated that approximately 34 subjects will be enrolled in the dose-escalation phase of the study. ET0038 will be administered orally once daily (QD) in 21-day treatment cycles.

Eligible Conditions

  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Study Objectives

3 Primary · 9 Secondary · Reporting Duration: Approximately 2 years

Approximately 2 years
Area under the curve
Changes in phospho-ERK levels
Cmax
Determination of Maximum Tolerated Dose (MTD) of ET0038
Disease Control Rate
Duration of response
NGS test of RTK/MAPK pathway genes
Number of participants with adverse events
Objective response rate
Recommended Phase 2 Dose (RP2D)
T1/2
Tmax
overall survival
progression-free survival

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Trial Design

1 Treatment Group

Dose Escalation
1 of 1
Experimental Treatment

34 Total Participants · 1 Treatment Group

Primary Treatment: ET0038 · No Placebo Group · Phase 1

Dose Escalation
Drug
Experimental Group · 1 Intervention: ET0038 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 2 years
Closest Location: BUMC - Mary Crowley Cancer Research Centers (MCCRC) · Dallas, TX
Photo of Dallas 1Photo of Dallas 2Photo of Dallas 3
N/AFirst Recorded Clinical Trial
2 TrialsResearching Solid Tumors, Advanced Solid Tumors
0 CompletedClinical Trials

Who is running the clinical trial?

Etern BioPharma (Shanghai) Co., LtdLead Sponsor
2 Previous Clinical Trials
74 Total Patients Enrolled
2 Trials studying Solid Tumors, Advanced Solid Tumors
74 Patients Enrolled for Solid Tumors, Advanced Solid Tumors

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You must have signed and dated a written informed consent prior to any study specific procedures, sampling and analyses.
You have a solid tumor and have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) exists.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.