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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

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 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

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

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.

Find a Location

Who is running the clinical trial?

Scorpion Therapeutics, Inc.Lead Sponsor
1 Previous Clinical Trials
400 Total Patients Enrolled
~80 spots leftby Jun 2027