ASN004 for Solid Tumors

(ASN004 Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ASN004, an experimental treatment for individuals with advanced solid tumors, to determine the safest high dose for future studies. Participants will receive ASN004 through an IV every 3 or 4 weeks, with gradually increasing doses. Suitable candidates include those with progressive cancers such as colorectal, breast, or lung cancer, who have not responded to standard treatments and have a tumor that hasn't been treated with radiation. As a Phase 1 trial, this research aims to understand how ASN004 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that ASN004 is likely to be safe for humans?

Research has shown that ASN004 was tested on marmoset monkeys and was well tolerated at doses up to 1.5 mg/kg every three weeks. These animals experienced more effects with higher doses but generally handled the treatment well. It is important to understand that this research is still in the early stages for humans. The current study is a Phase 1 trial, primarily focused on determining the highest safe dose of ASN004 for people. This stage of research is essential for understanding human tolerance and potential side effects. While ASN004 has shown promise in animal studies, researchers are still collecting data on its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ASN004 for solid tumors because it introduces a novel approach by using antibody-drug conjugates (ADCs) to target cancer cells more precisely. Unlike traditional chemotherapy, which attacks both healthy and cancerous cells, ASN004 links a potent drug to an antibody that specifically seeks out tumor cells, minimizing harm to normal tissues. This targeted mechanism has the potential to improve effectiveness and reduce side effects, making it a promising advancement over existing treatments.

What evidence suggests that ASN004 might be an effective treatment for solid tumors?

Research has shown that ASN004 holds promise for treating certain solid tumors. In studies with cervical cancer models, a single dose of ASN004 completely eliminated tumors, leaving survivors tumor-free. This result strongly indicates its potential effectiveness. ASN004 targets a protein called 5T4, commonly found in cancer cells. In this trial, participants will receive escalating doses of ASN004 to determine the optimal dose for further study. Early results suggest ASN004 could be a powerful option for treating advanced cancers, but further research is needed to fully understand its potential. ^{1 2 6 7 8}

Who Is on the Research Team?

Alison L Hannah, MD

Principal Investigator

Kirilys Therapeutics Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04410224?intr=ASN004&rank=1

Study of ASN004 in Patients With Advanced Solid Tumors The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

2. georgiacancerinfo.org georgiacancerinfo.org/clinical-trials/detail/5313

Study of ASN004 in Patients With Advanced Solid Tumors Summary. Participants in this study will receive ASN004 once every 3 or 4 weeks by intravenous infusion. The ASN004 dosing schedule may be modified based on ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34045226/

ASN004, A 5T4-targeting scFv-Fc Antibody-Drug ... A single dose of ASN004, as low as 1 mg/kg i.v., achieved complete tumor regression leading to tumor-free survivors in the A431 cervical cancer ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0960977624001619

Unveiling the future of breast cancer therapy: Cutting-edge ... Notably, among patients with active brain metastases, the 12-month PFS rate was even more impressive, reaching 66.7 % (95 % CI: 53.4–76.9) [33]. In comparison, ...

5. synapse.patsnap.com synapse.patsnap.com/drug/149e8141e83645c59431b1e06b97e3ff

ASN-004 - Drug Targets, Indications, Patents A single dose of ASN004, as low as 1 mg/kg i.v., achieved complete tumor regression leading to tumor-free survivors in the A431 cervical cancer model. In head- ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2022-03443

Study of ASN004 in Patients With Advanced Solid Tumors The study will test various doses of ASN004 to find out the highest safe dose to test in future trials. Eligible subjects will be sequentially enrolled in ...

7. aacrjournals.org aacrjournals.org/mct/article/doi/10.1158/1535-7163.MCT-20-0565/673333/am/ASN004-a-5T4-targeting-scFv-Fc-antibody-drug

ASN004, a 5T4-targeting scFv-Fc antibody-drug conjugate ... In marmoset monkeys, ASN004 was well tolerated at doses up to 1.5 mg/kg Q3W iv, and showed dose-dependent exposure, linear pharmacokinetics, and markedly low ...

8. clinicaltrialsarena.com clinicaltrialsarena.com/news/asana-solid-tumour-trial/

Asana doses first subject with ADC in Phase I solid tumour ... One dose of ASN004 offered complete and durable tumour regression resulting in tumour-free survivors, in preclinical cancer models. Asana ...