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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

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ClinicalTrials.gov Identifier: NCT06043817
Recruitment Status : Recruiting
First Posted : September 21, 2023
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
Scorpion Therapeutics, Inc.

Study Description
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Brief Summary:
Study STX-721-101 is an open label, Phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (PK) exposure, and preliminary antitumor activity of STX-721 in participants with non-small cell lung cancer (NSCLC) carrying EGFR/HER2 exon 20 insertion (ex20ins) mutations.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer NSCLC EGFR/HER2 Exon 20 Insertion Mutation Drug: STX-721 (Escalated) Drug: STX-721 (2 doses) Drug: STX-721 (RP2D) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : September 26, 2023
Estimated Primary Completion Date : June 1, 2027
Estimated Study Completion Date : June 1, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Part 1: Dose Escalation Drug: STX-721 (Escalated)
STX-721 dose will be escalated per Safety Evaluation Team (SET) decision and BLRM-design.
Experimental: Part 2: RP2D Selection Drug: STX-721 (2 doses)
Participants will receive 2 doses of STX-721.
Experimental: Part 3: Dose Expansion Drug: STX-721 (RP2D)
Participants will receive the RP2D of STX-721.


Outcome Measures
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Primary Outcome Measures :
  1. Part 1 Dose Escalation (MTD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment [ Time Frame: 28 days ]
  2. Part 1 Dose Escalation (OBD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment [ Time Frame: 28 days ]
  3. Part 2 RP2D Selection: C(max) of STX-721 [ Time Frame: 1 year ]
  4. Part 2 RP2D Selection: AUC(0-inf) of STX-721 [ Time Frame: 1 year ]
  5. Part 2 RP2D Selection: AUC(0-t) of STX-721 [ Time Frame: 1 year ]
  6. Part 2 RP2D Selection: AUC(0-τ) of STX-721 [ Time Frame: 1 year ]
  7. Part 2 RP2D Selection: Change from baseline in circulating tumor DNA (ctDNA) analysis of EGFR mutations [ Time Frame: 1 year ]
  8. Part 2 RP2D Selection: Change from baseline in EGFR signaling [ Time Frame: 1 year ]
  9. Part 2 RP2D Selection: Change in absolute value versus time in circulating tumor DNA (ctDNA) analysis of EGFR mutations [ Time Frame: 1 year ]
  10. Part 2 RP2D Selection: Change in absolute value versus time in EGFR signaling [ Time Frame: 1 year ]
  11. Part 2 RP2D Selection: Number of participants with confirmed objective response rate (ORR) defined as the percentage of participants with partial response (PR) or complete response (CR) based on RECIST v1.1 per investigator assessment. [ Time Frame: 1 year ]
  12. Part 3 Dose Expansion: Number of participants with confirmed ORR defined as the percentage of participants with PR or complete response CR based on RECIST v1.1 per investigator assessment. [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Has histologically- or cytologically confirmed diagnosis of NSCLC Stage IIIB/C or IV not eligible for curative intent surgery or chemoradiation.
  2. Tumor tissue EGFR exon 20 insertion mutations confirmed by qualified local laboratories.
  3. Has new or recent tumor biopsy (collected at screening, if feasible) or archival tumor specimen collected in the past 10 years available for genomic profiling (see lab manual for minimum tissue requirements).
  4. Is ≥18 years of age at the time of signing the ICF.
  5. Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Key Exclusion Criteria:

  1. Has a tumor that is known to harbor concurrent T790M and C797S resistance mutations.
  2. Has history (within ≤2 years before screening) of solid tumor or hematological malignancy that is histologically distinct from NSCLC.
  3. Has symptomatic brain or spinal metastases.
  4. Has toxicities from previous anticancer therapies that have not resolved to baseline levels or to CTCAE Grade ≤1, except for alopecia and peripheral neuropathy.
  5. 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06043817


Contacts
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Contact: For questions concerning enrollment Please email: clinicaltrials@scorpiontx.com

Locations
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United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
City of Hope Recruiting
Huntington Beach, California, United States, 92648
City of Hope Recruiting
Irvine, California, United States, 92618
United States, Virginia
NEXT Virginia Recruiting
Fairfax, Virginia, United States, 22031-2171
Taiwan
National Taiwan University Hospital Recruiting
Taipei City, Taiwan, 10002
Sponsors and Collaborators
Scorpion Therapeutics, Inc.
More Information
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Responsible Party: Scorpion Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT06043817    
Other Study ID Numbers: STX-721-101
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: April 18, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms