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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial studies a drug to treat NSCLC with EGFR/HER2 mutations. It looks at safety, effects, and potential effectiveness.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1 Dose Escalation (MTD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment

Part 1 Dose Escalation (OBD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment

Part 2 RP2D Selection: AUC(0-inf) of STX-721

+9 more

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Scorpion Therapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

400 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings in this trial for participants?

"An examination of the clinicaltrials.gov website confirms that this trial is not currently looking for participants. It was first published on September 25th, 2023 and last updated on September 18th, 2023. Despite being inactive, there are over 2000 other medical trials actively recruiting candidates at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

2023. "First-In-Human Study of STX-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06043817.