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

Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06043817
• Other study ID #: STX-721-101
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: September 26, 2023
• Est. completion date: June 1, 2028

Study information

• Verified date: April 2024
• Source: Scorpion Therapeutics, Inc.
• Contact: For questions concerning enrollment
• Phone: Please email:
• Email: clinicaltrials[@]scorpiontx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 1, 2028
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer
• NSCLC

Intervention

Drug:
• STX-721 (Escalated)
STX-721 dose will be escalated per Safety Evaluation Team (SET) decision and BLRM-design.
• STX-721 (2 doses)
Participants will receive 2 doses of STX-721.
• STX-721 (RP2D)
Participants will receive the RP2D of STX-721.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei City
United States	City of Hope	Duarte	California
United States	NEXT Virginia	Fairfax	Virginia
United States	City of Hope	Huntington Beach	California
United States	City of Hope	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Scorpion Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1 Dose Escalation (MTD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment		28 days
Primary	Part 1 Dose Escalation (OBD): Dose Escalation - Number of participants who experience at least 1 DLT during the first 28 days of treatment		28 days
Primary	Part 2 RP2D Selection: C(max) of STX-721		1 year
Primary	Part 2 RP2D Selection: AUC(0-inf) of STX-721		1 year
Primary	Part 2 RP2D Selection: AUC(0-t) of STX-721		1 year
Primary	Part 2 RP2D Selection: AUC(0-t) of STX-721		1 year
Primary	Part 2 RP2D Selection: Change from baseline in circulating tumor DNA (ctDNA) analysis of EGFR mutations		1 year
Primary	Part 2 RP2D Selection: Change from baseline in EGFR signaling		1 year
Primary	Part 2 RP2D Selection: Change in absolute value versus time in circulating tumor DNA (ctDNA) analysis of EGFR mutations		1 year
Primary	Part 2 RP2D Selection: Change in absolute value versus time in EGFR signaling		1 year
Primary	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.		1 year
Primary	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.		1 year