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

• Sponsor: Scorpion Therapeutics, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06043817
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 55.2
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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; Drug: STX-721; Drug: STX-721	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Sep 25, 2023
• Anticipated Primary Completion Date: Jul 17, 2026
• Anticipated Study Completion Date: May 1, 2028

Arms and Interventions

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

Outcome Measures

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 [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 [28 days]

3. Part 2 RP2D Selection: C(max) of STX-721 [1 year]

4. Part 2 RP2D Selection: AUC(0-inf) of STX-721 [1 year]

5. Part 2 RP2D Selection: AUC(0-t) of STX-721 [1 year]

6. Part 2 RP2D Selection: AUC(0-τ) of STX-721 [1 year]

7. Part 2 RP2D Selection: Change from baseline in circulating tumor DNA (ctDNA) analysis of EGFR mutations [1 year]

8. Part 2 RP2D Selection: Change from baseline in EGFR signaling [1 year]

9. Part 2 RP2D Selection: Change in absolute value versus time in circulating tumor DNA (ctDNA) analysis of EGFR mutations [1 year]

10. Part 2 RP2D Selection: Change in absolute value versus time in EGFR signaling [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. [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. [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	NEXT Virginia	Fairfax	Virginia	United States	22031-2171

Sponsors and Collaborators

• Scorpion Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Scorpion Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT06043817
• Other Study ID Numbers: STX-721-101
• First Posted: Sep 21, 2023
• Last Update Posted: Sep 21, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Sep 21, 2023