What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as targeted therapies and chemotherapy agents, often have a range of side effects. These can include fatigue, nausea, vomiting, diarrhea, and loss of appetite. Hematologic toxicities like neutropenia, anemia, and thrombocytopenia are also frequent. Additionally, patients may experience skin reactions, such as rash and pruritus, as well as liver function abnormalities. Specific targeted therapies can also lead to unique side effects based on their mechanism of action, such as hypertension or cardiotoxicity.

What prior FDA approvals exist?

FDA-approved treatments for solid tumors include tyrosine kinase inhibitors (TKIs) like pazopanib and erlotinib, which target specific enzymes involved in tumor growth. Immune checkpoint inhibitors such as nivolumab and pembrolizumab enhance the body's immune response against cancer cells. Additionally, radioligand therapies like lutetium Lu 177 vipivotide tetraxetan have been approved for specific types of metastatic cancers. These therapies represent a range of targeted and immunotherapeutic approaches that have shown efficacy in treating various solid tumors.

What other types of research exist?

Promising alternatives to ET0038 for solid tumors include: 1) Pembrolizumab, an immune checkpoint inhibitor, which has shown efficacy in various solid tumors. 2) Atezolizumab, another immune checkpoint inhibitor, used in combination with chemotherapy for non-small cell lung cancer and other solid tumors. 3) Cabozantinib, a tyrosine kinase inhibitor, effective in medullary thyroid cancer and other solid tumors. 4) Lutetium-177-PSMA-617, a radioligand therapy for metastatic castration-resistant prostate cancer. These therapies have demonstrated significant clinical activity and safety profiles in recent trials.

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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

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

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 more

Other 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).

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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.