What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly those involving dose-escalation studies like ASN004, often result in hematologic toxicities such as neutropenia, leukopenia, and thrombocytopenia, increasing the risk of infections and bleeding. Non-hematologic side effects include fatigue, nausea, vomiting, diarrhea, and mucositis. Organ-specific toxicities such as hepatotoxicity, nephrotoxicity, and cardiotoxicity may also occur, depending on the specific agents used. Careful monitoring and management of these side effects are essential to ensure patient safety and treatment efficacy.

What prior FDA approvals exist?

Several drugs have been approved by the FDA for the treatment of solid tumors following dose escalation studies to determine the highest safe dose. Pembrolizumab, an immune checkpoint inhibitor, was approved for various solid tumors after demonstrating efficacy and safety in phase I trials. Similarly, nivolumab, another immune checkpoint inhibitor, underwent dose escalation studies before its approval for multiple solid tumors. These treatments, like ASN004, involved careful dose escalation to establish the optimal therapeutic dose while monitoring for adverse effects.

What other types of research exist?

Promising novel alternatives to ASN004 for solid tumor patients in 2024 include: 1) Lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy showing efficacy in prostate cancer and potentially applicable to other solid tumors. 2) Pembrolizumab and nivolumab, immune checkpoint inhibitors that have shown success in various solid tumors. 3) Venetoclax combined with low-dose cytarabine, particularly for hematologic malignancies but with potential for solid tumors. 4) NBTXR3, a radioenhancer nanoparticle activated by radiotherapy, showing promise in soft tissue sarcomas and potentially other solid tumors.

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Monoclonal Antibodies

ASN004 for Solid Tumors (ASN004 Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Targeted therapy involves drugs designed to specifically target molecular pathways critical for tumor growth and survival, thereby minimizing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells more effectively. These mechanisms are vital for solid tumor patients as they offer different strategies to control tumor growth, improve survival rates, and potentially reduce side effects compared to traditional treatments.

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

Must not have

Patients with known history of left ventricular ejection fraction of < 50%

Hematologic malignancies and lymphomas

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Summary

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.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My heart's pumping ability is below normal.

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I have a blood cancer or lymphoma.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the maximum tolerated dose of ASN004

Secondary study objectives

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 study objectives

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

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ASN004

2022

Completed Phase 1

~20

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Targeted therapy involves drugs designed to specifically target molecular pathways critical for tumor growth and survival, thereby minimizing damage to normal cells. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells more effectively. These mechanisms are vital for solid tumor patients as they offer different strategies to control tumor growth, improve survival rates, and potentially reduce side effects compared to traditional treatments.