What is the mechanism of action of this treatment?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and metabolic inhibitors. Targeted therapies, such as tyrosine kinase inhibitors (TKIs), specifically inhibit proteins that drive cancer cell growth and survival, often targeting genetic mutations like EGFR or ALK. Metabolic inhibitors disrupt the metabolic pathways essential for cancer cell energy and growth. These treatments are important for NSCLC patients as they provide a personalized approach, potentially improving outcomes and reducing side effects compared to conventional chemotherapy.

What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and metabolic inhibitors. Targeted therapies, such as ALK and EGFR inhibitors, often cause side effects like fatigue, nausea, diarrhea, skin rash, and increased liver enzymes. Immune checkpoint inhibitors can lead to immune-related adverse events including pneumonitis, colitis, hepatitis, and endocrinopathies. Metabolic inhibitors may cause gastrointestinal disturbances, fatigue, and metabolic imbalances. Combining these therapies may increase the risk of overlapping toxicities, requiring careful monitoring.

What prior FDA approvals exist?

Several targeted therapies and metabolic inhibitors have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC). Pembrolizumab, a PD-1 inhibitor, has shown significant improvement in overall survival and progression-free survival when combined with chemotherapy in patients with advanced NSCLC. Atezolizumab, another immune checkpoint inhibitor targeting PD-L1, has been approved in combination with chemotherapy and bevacizumab for advanced nonsquamous NSCLC. Cemiplimab, a PD-1 inhibitor, has also been approved for patients with high PD-L1 expression. Additionally, trastuzumab deruxtecan, an antibody-drug conjugate targeting HER2 mutations, is approved for patients with HER2-mutant NSCLC. These therapies highlight the advancements in targeted and immune-based treatments for NSCLC.

What other types of research exist?

Promising novel alternatives for NSCLC treatment in 2024 include: 1) ASK120067, a third-generation EGFR inhibitor effective against EGFR T790M mutations; 2) Next-generation ALK inhibitors like alectinib, LDK378, and AP26113 for ALK-rearranged NSCLC; 3) PD-1/PD-L1 inhibitors such as pembrolizumab and nivolumab, which have shown durable responses in advanced NSCLC. These therapies target specific genetic mutations and pathways, offering potential benefits for patients with NSCLC.

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Monoclonal Antibodies

AMG 193 + IDE397 for Solid Cancers

Phase 1 & 2

Recruiting

Research Sponsored by Amgen

Eligibility Criteria Checklist

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

Must have

MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists

MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2 prior lines of systemic therapy

Must not have

Gastrointestinal tract disease causing the inability to take PO medication, malabsorption syndrome, requirement for IV alimentation, gastric/jejunal tube feeds, uncontrolled inflammatory gastrointestinal disease (eg, Crohn's disease, ulcerative colitis)

Radiologic or clinical evidence of spinal cord compression, untreated or symptomatic brain metastases or leptomeningeal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 up to approximately 2.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and best dose of two drugs, AMG 193 and IDE397, in adults with advanced cancers missing the MTAP gene, especially lung cancer. The goal is to see if this combination can effectively fight these cancers.

Who is the study for?

This trial is for adults with advanced solid tumors that can't be cured and have lost MTAP protein function. They should have tried up to two treatments for non-small cell lung cancer (NSCLC) without success, be able to swallow pills, and not have had certain bowel or heart issues recently. People who've taken MAT2A or PRMT5 inhibitors or strong drug modifiers can't join.

What is being tested?

The study tests the safety and ideal dose of a new treatment combo: AMG 193 with IDE397 in patients whose tumors lack MTAP protein. It's also looking at how well this combination works against advanced NSCLC that has spread or cannot be removed by surgery.

What are the potential side effects?

Possible side effects include typical reactions related to the immune system's response to the drugs, digestive disturbances due to oral medication intake, as well as any organ-specific issues arising from the novel mechanism of action these drugs employ.

Eligibility Criteria

Inclusion Criteria

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

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My cancer lacks MTAP and has no standard treatment available.

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My NSCLC lacks MTAP and has worsened after 1-2 treatments.

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My cancer has spread and cannot be cured with surgery or radiation.

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My tests show I have a specific genetic change (MTAP loss).

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I can swallow pills and will track my medication intake.

Exclusion Criteria

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

Select...

I do not have a digestive condition that prevents me from taking pills.

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I have untreated brain issues or spinal cord compression due to cancer.

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I have previously been treated with an MAT2A or PRMT5 inhibitor.

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More than a quarter of my bone marrow has been exposed to radiation.

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I haven't taken strong medication that affects liver enzymes recently.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 up to approximately 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 up to approximately 2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 up to approximately 2.5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Secondary study objectives

Part 2: Number of Participants Experiencing TEAEs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose Expansion of AMG 193 Combined With IDE397Experimental Treatment2 Interventions

AMG 193 and IDE397 will be administered PO in cycles of 21 days.

Group II: Part 1: Dose Exploration of AMG 193 Combined With IDE397Experimental Treatment2 Interventions

Participants will receive escalating doses of AMG 193 and IDE397 administered orally (PO) in cycles of 21 days.

0 / 10Eligibility 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 Non-Small Cell Lung Cancer (NSCLC) include targeted therapies and metabolic inhibitors. Targeted therapies, such as tyrosine kinase inhibitors (TKIs), specifically inhibit proteins that drive cancer cell growth and survival, often targeting genetic mutations like EGFR or ALK. Metabolic inhibitors disrupt the metabolic pathways essential for cancer cell energy and growth. These treatments are important for NSCLC patients as they provide a personalized approach, potentially improving outcomes and reducing side effects compared to conventional chemotherapy.

Emerging therapeutic agents for lung cancer.