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NCT06043817 | RECRUITING | Non-Small Cell Lung Cancer

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:

Antares Therapeutics, Inc

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

Non-Small Cell Lung Cancer

NSCLC

EGFR/HER2 Exon 20 Insertion Mutation

Intervention/treatment

STX-721 (Escalated)

STX-721 (3 dose levels)

STX-721 (RP2D)

Phase

PHASE1

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 185 participants
Masking : NONE
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 : 2023-09-26
Estimated Primary Completion Date : 2027-06-01
Estimated Study Completion Date : 2028-06-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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. Part 1: Tumor tissue EGFR or HER2 exon 20 insertion mutations confirmed by qualified local laboratories. Parts 2 and 3: EGFR exon 20 insertion mutations confirmed by qualified local laboratories
  • 3. Part 1: Has received all approved therapies for advanced or metastatic NSCLC or is ineligible. Part 2 and Part 3: Has received at least 1, but not more than 2, prior lines of treatment for advanced or metastatic NSCLC, 1 of which must be platinum-based chemotherapy unless contraindicated
  • 4. Has documented tumor progression (based on radiological imaging)
  • 5. 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
  • 6. Has at least one measurable tumor lesion per RECIST v1.1
  • 7. Is ≥18 years of age at the time of signing the ICF
  • 8. 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 EGFR ex20ins p.H773\_V774insH variant, or any EGFR kinase domain activating mutation concurrent with either a T790M and/or 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
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

Location Details

NCT06043817

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

City of Hope

Duarte, California, United States, 91010

RECRUITING

United States, California

City of Hope

Huntington Beach, California, United States, 92648

RECRUITING

United States, California

City of Hope

Irvine, California, United States, 92618

RECRUITING

United States, North Carolina

Levine Cancer Institute - Charlotte

Charlotte, North Carolina, United States, 28204-2990

RECRUITING

United States, Pennsylvania

Thomas Jefferson University Research Facility

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Tennessee

SCRI Oncology Partners - PPDS

Nashville, Tennessee, United States, 37203

RECRUITING

United States, Utah

University of Utah - Huntsman Cancer Institute - PPDS

Salt Lake City, Utah, United States, 84112-5550

RECRUITING

United States, Virginia

NEXT Virginia

Fairfax, Virginia, United States, 22031-2171

RECRUITING

France, Loire-Atlantique

EDOG Western Cancer Institute - PPDS

Saint-Herblain, Loire-Atlantique, France, 44115

RECRUITING

France,

Claudius Regaud Institute - PPDS

Toulouse, France, 31059

RECRUITING

France,

Gustave Roussy

Villejuif, France, 94800

RECRUITING

Germany,

Charité - University Medicine Berlin (CBF) - Hindenburgdamm 30

Berlin, Germany, 12203

RECRUITING

Germany,

Carl Gustav Carus University Hospital at the TU Dresden

Dresden, Germany, 01307

RECRUITING

Netherlands,

Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital

Amsterdam, Netherlands, 1066

RECRUITING

South Korea,

Chungbuk National University Hospital

Cheongju-si, South Korea, 28644

RECRUITING

Spain, Malaga

Regional University Hospital of Malaga - General Hospital

Málaga, Malaga, Spain, 29010

RECRUITING

Spain,

Vall dHebron Oncology Research Institute (VHIO) - EPON

Barcelona, Spain, 8035

RECRUITING

Spain,

Ramon y Cajal University Hospital

Madrid, Spain, 28034

RECRUITING

Spain,

Virgen del Rocio University Hospital

Seville, Spain, 41013

RECRUITING

Taiwan,

National Taiwan University Hospital

Taipei, Taiwan, 10002

RECRUITING

Taiwan,

Taipei Veterans General Hospital

Taipei, Taiwan, 11217