What side effects are associated with this type of intervention?

Common treatments for solid tumors, including chemotherapy, targeted therapy, and immunotherapy, often have overlapping side effects. Chemotherapy can cause myelosuppression, nausea, vomiting, fatigue, and hair loss. Targeted therapies may lead to hypertension, diarrhea, and skin rashes. Immunotherapies, such as checkpoint inhibitors, can result in immune-related adverse events like colitis, dermatitis, hepatitis, and endocrinopathies. These side effects reflect the broad impact of these treatments on the body.

What prior FDA approvals exist?

The FDA has approved several treatments for advanced solid tumors, including immunotherapies like pembrolizumab and nivolumab, which target PD-1/PD-L1 pathways to enhance the immune response against cancer cells. Targeted therapies such as dabrafenib and trametinib, which inhibit BRAF and MEK pathways respectively, have been approved for BRAF V600-mutant melanoma. Additionally, combination therapies like atezolizumab plus bevacizumab have been approved for advanced renal cell carcinoma. These approvals highlight the diverse strategies employed in treating advanced solid tumors, focusing on both immune modulation and targeted molecular inhibition.

What other types of research exist?

Promising novel alternatives to ATRN-119 for solid tumor patients include: 1) Dabrafenib/Trametinib combination therapy and Vemurafenib monotherapy for BRAF V600E mutated anaplastic thyroid cancer, 2) Abiraterone plus Niraparib for metastatic castration-resistant prostate cancer with homologous recombination repair deficiency, 3) Lutetium Lu 177 vipivotide tetraxetan for prostate cancer, and 4) Nivolumab plus Ipilimumab for advanced renal cell carcinoma. These therapies have demonstrated efficacy in clinical trials and may be considered as treatment options in 2024.

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ATRN-119 for Advanced Cancer (ABOYA-119 Trial)

Phase 1 & 2

Recruiting

Led By Geoffrey Shapiro, MD, PhD

Research Sponsored by Atrin Pharmaceuticals

Eligibility Criteria Checklist

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

Must have

DNA damage response (DDR) mutations documented in the past medical record or confirmed during the screening period

Subject must be capable of oral administration of study medication

Must not have

Known human immunodeficiency virus infection (HIV)

Current or past diagnosis of leukemia within the past 5 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to day 56

Awards & highlights

Summary

This trial is testing a new oral drug called ATRN-119 in patients with advanced solid tumors. The goal is to see if it is safe and effective. ATRN-119 works by stopping cancer cells from growing and spreading.

Who is the study for?

This trial is for adults with advanced solid tumors who have specific DNA damage response mutations. They must be able to take pills, have a life expectancy of at least 3 months, and measurable disease by certain medical imaging criteria. People can't join if they've had recent surgery, are on strong CYP3A4 or CYP2D6 inhibitors/inducers, had leukemia in the last 5 years, unstable heart conditions, known HIV infection, uncontrolled high blood pressure, recent non-cancer related GI bleeding or therapy within 4 weeks.

What is being tested?

The study tests ATRN-119's safety and effectiveness when taken orally by patients with advanced solid tumors. It's an open-label Phase 1/2a trial which means everyone knows what treatment they're getting and it combines initial testing (Phase 1) with early efficacy evaluation (Phase 2a).

What are the potential side effects?

While the side effects of ATRN-119 aren't listed here specifically since this is an early-phase trial assessing safety and effectiveness; common side effects may include nausea, fatigue, allergic reactions or other drug-specific adverse events.

Eligibility Criteria

Inclusion Criteria

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

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My records show I have DNA damage response mutations.

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I can take pills by mouth.

Exclusion Criteria

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

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I have HIV.

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I was diagnosed with leukemia in the last 5 years.

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I am not taking strong drugs that affect liver enzymes CYP3A4 and CYP2D6.

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I am not currently fighting an infection or taking antibiotics/antivirals.

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I've had radiotherapy on the cancer spot unless it's gotten worse.

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My blood pressure is not controlled with medication.

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I had surgery within the last week before starting ATRN-119.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to day 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to day 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 56 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Treatment Emergent Adverse Events (TEAEs) will be collected and evaluated based on summary statistics