STX-721 for Non-Small Cell Lung Cancer

Recruiting at 19 trial locations

Overseen By For questions concerning enrollment

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Scorpion Therapeutics, Inc.

Disqualifiers: EGFR mutations, Brain metastases, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It is best to discuss this with the trial team or your doctor.

What makes the drug STX-721 unique for treating non-small cell lung cancer?

The drug STX-721 is unique because it may target specific molecular pathways in non-small cell lung cancer, potentially offering a new approach compared to existing treatments. While the exact mechanism of STX-721 is not detailed, it could involve novel targets or combinations that are not addressed by current therapies. ^{1 2 3 4 5}

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

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

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

Exclusion Criteria

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

My tumor has specific mutations known as T790M and C797S.

Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., could compromise the participant's well-being) or would prevent, limit, or confound the protocol-specified assessments.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of STX-721 to evaluate safety and tolerability

8-12 weeks

RP2D Selection

Participants receive the recommended Phase 2 dose (RP2D) to further assess safety and pharmacokinetics

8-12 weeks

Dose Expansion

Participants receive the RP2D to evaluate preliminary antitumor activity

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• STX-721 (Monoclonal Antibodies)

Trial Overview 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.

Participant Groups

Group I: Part 3: Dose Expansion Experimental Treatment 1 Intervention

Group II: Part 2: RP2D Selection Experimental Treatment 1 Intervention

Group III: Part 1: Dose Escalation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Scorpion Therapeutics, Inc.

Lead Sponsor

Trials

2

Recruited

520+

Findings from Research

A new orthotopic non-small-cell lung cancer (NSCLC) mouse model was successfully established, allowing for effective testing of therapies, including lipid-based nanoparticles.

Lipid-based nanoparticles containing Br-C16-DX significantly improved survival outcomes compared to Taxotere, with 35 days longer progression-free survival and 27 days longer median survival, indicating their potential as a more effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a novel orthotopic non-small cell lung cancer model and therapeutic benefit of 2'-(2-bromohexadecanoyl)-docetaxel conjugate nanoparticles. Peng, L., Feng, L., Yuan, H., et al.[2021]

Squamous cell lung cancer (sqCLC) is challenging to treat due to factors like older patient age, late-stage diagnosis, and high comorbidity rates, leading to median survival times of only 9 to 11 months.

Recent advancements in targeted therapies, including monoclonal antibodies and immunotherapies, have shown modest survival benefits for sqCLC patients, highlighting the need for ongoing research into actionable molecular targets and effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incremental Innovation and Progress in Advanced Squamous Cell Lung Cancer: Current Status and Future Impact of Treatment. Langer, CJ., Obasaju, C., Bunn, P., et al.[2018]

In a study of 41 patients with unresectable stage III non-small-cell lung cancer, the combination of oral S-1 and cisplatin with thoracic radiotherapy resulted in a high objective response rate of 87.8%, indicating strong efficacy.

The treatment also demonstrated favorable safety profiles, with manageable hematological toxicities and only mild non-hematological side effects, suggesting it could be a promising option for patients with locally advanced NSCLC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of oral S-1 and cisplatin with concurrent radiotherapy for locally advanced non-small-cell lung cancer. Kaira, K., Tomizawa, Y., Yoshino, R., et al.[2013]

Detection of FGFR1 mRNA is a more reliable predictor of response to FGFR inhibitors in lung squamous cell carcinoma (SqCC) than simply measuring FGFR1 gene amplification, based on patient-derived xenograft (PDX) models.

Combining FGFR tyrosine kinase inhibitors with cisplatin significantly enhances tumor cell death and prolongs survival in animal models, suggesting a promising treatment strategy for patients with FGFR1-overexpressing non-small cell lung cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cisplatin Increases Sensitivity to FGFR Inhibition in Patient-Derived Xenograft Models of Lung Squamous Cell Carcinoma. Weeden, CE., Holik, AZ., Young, RJ., et al.[2020]

Monoclonal antibody NJ001 significantly inhibits the migration and invasiveness of human lung adenocarcinoma cells, reducing their invasive activity by 65%.

The mechanism of action involves the upregulation of tissue inhibitor of matrix metalloproteinase-3 (TIMP-3) through direct transcriptional regulation of FOXP1, suggesting potential clinical applications for NJ001 in preventing and treating metastatic lung adenocarcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MAb NJ001 inhibits lung adenocarcinoma invasiveness by directly regulating TIMP-3 promoter activity via FOXP1 binding sites. Gu, C., Luo, Y., Zhang, S., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Development of a novel orthotopic non-small cell lung cancer model and therapeutic benefit of 2'-(2-bromohexadecanoyl)-docetaxel conjugate nanoparticles. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Incremental Innovation and Progress in Advanced Squamous Cell Lung Cancer: Current Status and Future Impact of Treatment. [2018]

3. Ireland pubmed.ncbi.nlm.nih.gov

Phase II study of oral S-1 and cisplatin with concurrent radiotherapy for locally advanced non-small-cell lung cancer. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Cisplatin Increases Sensitivity to FGFR Inhibition in Patient-Derived Xenograft Models of Lung Squamous Cell Carcinoma. [2020]

5. Singapore pubmed.ncbi.nlm.nih.gov

MAb NJ001 inhibits lung adenocarcinoma invasiveness by directly regulating TIMP-3 promoter activity via FOXP1 binding sites. [2021]