ET0038 for Advanced Cancer

(FIRST Trial)

Overseen By Xin Luo

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Etern BioPharma (Shanghai) Co., Ltd

Must not be taking: Steroids, Anticancer drugs

Disqualifiers: CNS tumor, Autoimmune disease, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a new oral drug, ET0038, for individuals with advanced solid tumors—cancers that have spread and cannot be treated with surgery or radiation. The study aims to determine the appropriate dose for future research by gradually increasing the amount given to participants. Eligible individuals should have a solid tumor unresponsive to standard treatments or lack available standard treatments. Participants must have at least one tumor that can be clearly measured using scans. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had any investigational drugs or systemic anticancer treatment within 28 days before starting the trial.

Is there any evidence suggesting that ET0038 is likely to be safe for humans?

Research has shown that ET0038 remains under investigation to determine its safety for individuals with advanced solid tumors. These studies focus on how well participants tolerate the treatment and whether any major side effects occur. Currently, detailed safety information is limited because ET0038 is in the early stages of testing.

ET0038 is an oral medication being studied for its ability to target specific pathways in cancer cells. Although promising, the current research primarily aims to find the right dose and observe how participants' bodies respond to the drug over time.

Since ET0038 has not yet received approval for any condition, no long-term safety information from other uses exists. While scientists remain hopeful, safety details are still being developed. Researchers closely monitor study participants to manage any potential side effects promptly. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for advanced cancer, which often include chemotherapy, radiation, and targeted therapies, ET0038 is unique because it is taken orally and works by escalating doses to find the most effective and safe dose. Researchers are excited about ET0038 because it potentially offers a more convenient administration method compared to intravenous treatments and may have a novel mechanism of action that targets cancer cells differently. This could lead to fewer side effects and improved patient outcomes, which are crucial for those with advanced stages of cancer.

What evidence suggests that ET0038 might be an effective treatment for advanced cancer?

Research has shown that ET0038, the investigational treatment in this trial, could be promising for advanced solid tumors. ET0038 blocks SHP2, a protein that aids cancer cell growth and spread. Studies have found that inhibiting SHP2 can enhance the effectiveness of other cancer treatments, such as immune therapies. Although direct data on ET0038 remains limited, other SHP2-blocking drugs have successfully halted tumor growth. This suggests that ET0038 might slow down or shrink tumors in some patients. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I agree to use effective birth control during and for 12 weeks after the trial.

I have a tumor larger than 10mm (or a lymph node larger than 15mm) that hasn't been treated with radiation.

My cancer has grown despite treatment, or I can't tolerate standard treatments, or there's no standard treatment for my cancer.

Exclusion Criteria

I have had COVID-19 or tested positive for it recently.

I have or had an autoimmune disease like lupus, arthritis, or psoriasis.

I do not have major eye problems like severe vision loss or uncontrolled glaucoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Dose-Escalation Treatment

Participants receive oral ET0038 in escalating doses to determine the maximum tolerated dose (MTD) over 21-day cycles

21 days per cycle, up to 2 years

Multiple visits per cycle (in-person)

Dose-Expansion Treatment

Participants with specific mutations receive ET0038 to assess efficacy and safety

21 days per cycle, up to 2 years

Multiple visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 2 years

What Are the Treatments Tested in This Trial?

Interventions

• ET0038

Trial Overview 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.

How Is the Trial Designed?

Group I: Dose Escalation Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Etern BioPharma (Shanghai) Co., Ltd

Lead Sponsor

Trials

3

Recruited

110+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05525559

SHP2 Inhibitor ET0038 Monotherapy in Patients With ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10670368/

Overcoming Immune Checkpoint Therapy Resistance with ... This is a thorough literature review of SHP2 inhibition, its application in cancer therapy and current uses as an immune modulator.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12278243/

Targeting SHP2: Dual breakthroughs in colorectal cancer ... The combination of SHP099 and anti-PD-1 antibodies achieved significantly higher efficacy in suppressing tumor growth compared to monotherapy[40 ...

4. targetedonc.com targetedonc.com/view/shp2-inhibitors-undergo-exploration-in-combinations

SHP2 Inhibitors Undergo Exploration in Combinations SHP2 inhibition remains a focus of ongoing research because of its role in signaling pathways across cancer settings, but an SHP2 inhibitor remains elusive.

5. nature.com nature.com/articles/s41392-023-01589-z

Recent advances in targeting the “undruggable” proteins ... trial (NCT05525559) was conducted to investigate the efficacy of ET0038 monotherapy in the treating advanced solid tumors. ICP-189 (89) is a ...

6. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cac2.12548

Protein tyrosine phosphatases: emerging role in cancer ... Ongoing clinical trials are currently underway to assess the safety and efficacy of combination therapy in advanced-stage tumors. ... data ...

7. withpower.com withpower.com/trial/phase-1-solid-tumors-advanced-solid-tumors-10-2022-fbf2d

ET0038 for Advanced Cancer · Info for Participants Trial Overview 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.