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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
No Placebo-Only Group
Summary
This trial tests a new oral drug, ET0038, in patients with advanced solid tumors, focusing on those with certain genetic changes. The study aims to see if the drug is safe and effective by blocking cancer growth pathways.
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.
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.
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Determination of Maximum Tolerated Dose (MTD) of ET0038
Number of participants with adverse events
Recommended Phase 2 Dose (RP2D)
Secondary study objectives
Area under the curve
Cmax
Disease Control Rate
+6 moreOther study objectives
Changes in phospho-ERK levels
NGS test of RTK/MAPK pathway genes
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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).
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects.
Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular abnormalities in cancer cells, thereby reducing damage to normal cells and improving efficacy. Immunotherapy, including checkpoint inhibitors, enhances the body's immune response against cancer cells.
These mechanisms are crucial for solid tumor patients as they offer different approaches to control tumor growth, improve survival rates, and potentially reduce side effects compared to traditional treatments.
Current trends and future directions in the genetic therapy of human neoplastic disease.
Current trends and future directions in the genetic therapy of human neoplastic disease.
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Who is running the clinical trial?
Etern BioPharma (Shanghai) Co., LtdLead Sponsor
2 Previous Clinical Trials
74 Total Patients Enrolled
Media Library
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.