ASN004 for Solid Tumors

(ASN004 Trial)

Recruiting at 6 trial locations

Overseen By Alison L Hannah, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kirilys Therapeutics

Disqualifiers: Hematologic malignancies, Brain metastases, others

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

Compensation: Varies

Number of Visits: 3

Duration: Up to 1 year

19 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests ASN004, a new drug given through an IV periodically, to find the safest dose. It involves patients who meet specific criteria. Researchers will study how the drug moves and acts in the body to determine the best dose for future trials.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What makes ASN004 unique compared to other cancer drugs?

ASN004 is unique because it may involve arsenic sulfide, a component known for its use in traditional Chinese medicine, which has shown potential in inducing cancer cell death (apoptosis) in solid tumors. This mechanism of action is different from many standard cancer treatments, which often focus on directly killing cancer cells or inhibiting their growth. ^{1 2 3 4 5}

Research Team

Alison L Hannah, MD

Principal Investigator

Kirilys Therapeutics Inc.

Eligibility Criteria

Adults with advanced solid tumors who've tried all standard treatments or have none available can join. They need a measurable tumor lesion, good organ function, and an ECOG status of 0 or 1. Women must not be pregnant/breastfeeding and use contraception if of childbearing potential; men must also agree to contraception. Patients willing to provide tumor tissue for testing are required.

Inclusion Criteria

I agree to use contraception and not donate sperm for 3 months after my last treatment dose.

My tumor shows 5T4 expression with an H score of ≥ 10.

I am fully active or can carry out light work.

Exclusion Criteria

Serious concurrent medical conditions

My heart's pumping ability is below normal.

I have a blood cancer or lymphoma.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive escalating doses of ASN004 to identify the maximum tolerated dose

Up to 1 year

Every 3 or 4 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ASN004

Trial Overview The trial is testing ASN004, given by IV every few weeks at increasing doses to find the highest safe dose for future studies. Participants will receive different amounts in groups one after another based on safety reviews.

Participant Groups

Group I: ASN004 ascending doses Experimental Treatment 1 Intervention

Patients will receive escalating doses of ASN004 to identify the best dose for further study.

Who Is Running the Clinical Trial?

Kirilys Therapeutics

Lead Sponsor

Trials

10

Recruited

730+

Kirilys Therapeutics, Inc.

Lead Sponsor

Trials

12

Recruited

760+

Asana BioSciences

Lead Sponsor

Trials

12

Recruited

760+

Kirilys Therapeutics Inc.

Lead Sponsor

Trials

1

Recruited

20+

References

1. United States pubmed.ncbi.nlm.nih.gov

Antisense oligonucleotides in the treatment of non-small-cell lung cancer. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Arsenic sulfide, the main component of realgar, a traditional Chinese medicine, induces apoptosis of gastric cancer cells in vitro and in vivo. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

New tumor-targeted nanosized delivery carrier for oligonucleotides: characteristics in vitro and in vivo. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

In Vivo Administration of Therapeutic Antisense Oligonucleotides. [2021]

5. Greece pubmed.ncbi.nlm.nih.gov

Arsenic sulfide as a potential anti‑cancer drug. [2022]