What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) with EGFR/HER2 exon 20 insertion mutations include EGFR tyrosine kinase inhibitors (TKIs) and HER2-targeted therapies. EGFR TKIs, such as erlotinib and gefitinib, often cause side effects like rash, diarrhea, and liver enzyme abnormalities. HER2-targeted therapies, such as trastuzumab-emtansine, can lead to fatigue, nausea, and interstitial lung disease. Chemotherapy regimens, including carboplatin and paclitaxel, are associated with neutropenia, anemia, and nausea. Immunotherapy agents, like pembrolizumab, may cause immune-related adverse events such as colitis, pneumonitis, and dermatitis.

What prior FDA approvals exist?

Several targeted therapies have received FDA approval for the treatment of Non-Small Cell Lung Cancer (NSCLC) with specific genetic mutations. For EGFR exon 20 insertion mutations, amivantamab and mobocertinib have been approved. Amivantamab is a bispecific antibody targeting EGFR and MET, while mobocertinib is a tyrosine kinase inhibitor specifically designed for EGFR exon 20 insertions. For HER2 mutations, fam-trastuzumab deruxtecan has shown efficacy in clinical trials and is used in HER2-mutant NSCLC. These therapies represent significant advancements in personalized treatment for NSCLC patients with these specific genetic alterations.

What other types of research exist?

Promising alternatives to STX-721 for NSCLC patients with EGFR/HER2 exon 20 insertion mutations include: 1) Fam-trastuzumab deruxtecan, which has shown a 24.5% response rate in HER2-overexpressed NSCLC. 2) Anti-PD-1 therapy, such as nivolumab, which has shown a 60% response rate in a small cohort of patients with large cell neuroendocrine carcinoma. These therapies represent novel and potentially effective options for patients considering treatment in 2024.

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Monoclonal Antibodies

STX-721 for Non-Small Cell Lung Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Scorpion Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Is ≥18 years of age at the time of signing the ICF.

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

Must not have

Has symptomatic brain or spinal metastases.

Has a tumor that is known to harbor concurrent T790M and C797S resistance mutations.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called STX-721 to see if it is safe and effective for people with a specific type of lung cancer that has certain genetic mutations. The drug works by blocking proteins that help cancer cells grow.

Who is the study for?

This trial is for adults over 18 with advanced non-small cell lung cancer (NSCLC) that can't be treated with surgery or chemoradiation and have specific EGFR exon 20 mutations. Participants should be relatively healthy, with a performance status showing they can carry out daily activities with little or no help.

What is being tested?

STX-721 is being tested in this study to see if it's safe and how well it works against NSCLC with certain genetic changes. Patients will receive different doses of STX-721, including increased amounts to find the right dose, followed by a phase where everyone gets the best dose found.

What are the potential side effects?

Since STX-721 is new, its side effects aren't fully known yet. However, like other cancer drugs, potential side effects could include nausea, fatigue, skin reactions at the injection site, and possibly allergic reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My tumor has a specific genetic change known as EGFR exon 20 insertion.

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My lung cancer is at a stage where surgery or combined chemotherapy and radiation can't cure it.

Exclusion Criteria

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

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I have cancer that has spread to my brain or spine and is causing symptoms.

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My tumor has specific mutations known as T790M and C797S.

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My side effects from cancer treatments have mostly gone away, except for hair loss and nerve issues.

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I had a different type of cancer than NSCLC within the last 2 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 3: Dose ExpansionExperimental Treatment1 Intervention

Group II: Part 2: RP2D SelectionExperimental Treatment1 Intervention

Group III: Part 1: Dose EscalationExperimental Treatment1 Intervention

0 / 8Eligibility 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

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) with EGFR/HER2 exon 20 insertion mutations are targeted therapies. These treatments work by specifically inhibiting the mutated EGFR or HER2 proteins that drive cancer cell growth and survival. For example, drugs like STX-721 are designed to block the abnormal signaling pathways caused by these mutations, effectively halting tumor progression. This targeted approach is particularly important for NSCLC patients with these mutations, as they often do not respond well to traditional chemotherapy, making targeted therapies a more promising and effective treatment option.

Novel drugs targeting EGFR and HER2 exon 20 mutations in metastatic NSCLC.