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Monoclonal Antibodies

ASN004 for Solid Tumors (ASN004 Trial)

Phase 1

Waitlist Available

Research Sponsored by Kirilys Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

For Dose Expansion patients, eligible tumor histologies will be limited to those malignancies known to have highest expression of 5T4 including colorectal, breast, ovarian, lung, liver, and renal carcinomas. A maximum of 3 prior cytotoxic chemotherapy regimens is permitted for advanced disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

ASN004 Trial Summary

This trial is testing a new drug, ASN004, given intravenously every 3 weeks. The goal is to find the highest safe dose of ASN004 to test in future trials. Up to 43 patients will be enrolled in seven dose levels, with up to six subjects per dose level.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Specific side effects of ASN004 aren't listed but may include typical reactions related to cancer drug infusions such as fatigue, nausea, allergic reactions, and possibly effects on blood counts or organ functions.

ASN004 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My cancer is one of: colorectal, breast, ovarian, lung, liver, renal and I've had 3 or fewer chemo treatments for advanced disease.

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I have been diagnosed with an advanced solid tumor cancer.

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I am 18 years old or older.

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Standard treatments have not worked for me or are not available.

ASN004 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Determine the maximum tolerated dose of ASN004

Secondary outcome measures

Appearance of new tumor lesions

Calculate the maximum plasma concentration at steady state

Calculate the pharmacokinetic (PK) area under the plasma concentration of ASN004

+3 more

Other outcome measures

Correlate 5T4 oncofetal protein (5T4) expression and clinical efficacy

ASN004 Trial Design

1Treatment groups

Experimental Treatment

Group I: ASN004 ascending dosesExperimental Treatment1 Intervention

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kirilys TherapeuticsLead Sponsor

9 Previous Clinical Trials

709 Total Patients Enrolled

Kirilys Therapeutics, Inc.Lead Sponsor

11 Previous Clinical Trials

744 Total Patients Enrolled

Asana BioSciencesLead Sponsor

11 Previous Clinical Trials

744 Total Patients Enrolled

Media Library

ASN004 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04410224 — Phase 1

Solid Tumors Research Study Groups: ASN004 ascending doses

Solid Tumors Clinical Trial 2023: ASN004 Highlights & Side Effects. Trial Name: NCT04410224 — Phase 1

ASN004 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04410224 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment for this trial?

"Affirmative. Clinicaltrials.gov presents evidence that this trial, initially posted on December 10th 2021 and recently edited on June 27th 2022, is actively recruiting 43 individuals from 3 sites."

Answered by AI

Are there any enrolment opportunities in this research endeavor?

"As of June 27th 2022, clinicaltrials.gov verifies that this experiment is still actively enrolling participants. This research was initially announced on December 10th 2021."

Answered by AI

What safety parameters have been established for ASN004?

"Due to its experimental nature, ASN004's safety has been assessed as 1. This is because Phase 1 trials have minimal data regarding their efficacy and risk profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of ASN004 in Patients With Advanced Solid Tumors

2022. "Study of ASN004 in Patients With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04410224.