EphA2 siRNA for Cancer

Overseen By Shannon Westin, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Investigational agents

Disqualifiers: CNS disease, Cardiovascular disease, HIV, others

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

Compensation: Varies

Number of Visits: 2

Duration: 21 days per cycle

49 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase I trial studies the side effects and best dose of EphA2 siRNA in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or have come back after a period of improvement (recurrent). EphA2-targeting DOPC-encapsulated siRNA may slow the growth of tumor cells by shutting down the activity of a gene that causes tumor growth.

Research Team

Shannon Westin, MD

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults with advanced or recurrent solid tumors. Participants must have a performance status indicating they can carry out some activity and care for themselves, be willing to undergo biopsies, and not be on other cancer treatments. They should have measurable disease, acceptable organ function tests, no active infections requiring IV antibiotics, and agree to use birth control. Those with certain cardiovascular diseases, bleeding risks, severe allergies to similar drugs or components used in the study are excluded.

Inclusion Criteria

I agree to use contraception throughout the study.

I do not have an infection that needs IV antibiotics.

I stopped any hormone treatments for my cancer a week ago.

Exclusion Criteria

Patients who are pregnant or nursing

I have a history or signs of brain or spinal cord disease.

Patients who are ineligible to undergo an MRI scan for reasons such as claustrophobia or the presence of implanted devices or metallic foreign bodies that are not magnetic resonance (MR) compatible

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive EphA2-targeting DOPC-encapsulated siRNA intravenously over 120 minutes on days 1 and 4, with cycles repeating every 21 days

21 days per cycle

2 visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment completion

Up to 5 years

Treatment Details

Interventions

• EphA2-targeting DOPC-encapsulated siRNA

Trial Overview The trial is testing EphA2 siRNA encapsulated in DOPC liposomes which might inhibit tumor growth by targeting a gene linked to cancer progression. It's a phase I study aiming to determine the safest dose while observing how well patients tolerate it and its effect on their tumors through biomarker analysis.

Participant Groups

Group I: Treatment (EphA2-targeting DOPC-encapsulated siRNA) Experimental Treatment 3 Interventions

Patients receive EphA2-targeting DOPC-encapsulated siRNA IV over 120 minutes on days 1 and 4. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Gateway for Cancer Research

Collaborator

Trials

47

Recruited

2,500+

Institutional Funding for Federally Supported Clinical Trials (IFSCT)

Collaborator

Trials

1

Recruited

50+