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

34 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+