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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

185

Participants

Timeline

Start Date

September 26, 2023

Primary Completion Date

June 1, 2027

Study Completion Date

June 1, 2028

Conditions
Non-Small Cell Lung CancerNSCLCEGFR/HER2 Exon 20 Insertion Mutation
Interventions
DRUG

STX-721 (Escalated)

STX-721 dose will be escalated per cBLRM-design.

DRUG

STX-721 (3 dose levels)

Participants will receive STX-721 at one of two dose levels.

DRUG

STX-721 (RP2D)

Participants will receive the RP2D of STX-721.

Trial Locations (21)

1066

RECRUITING

Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis, Amsterdam

8035

RECRUITING

Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON, Barcelona

10002

RECRUITING

National Taiwan University Hospital, Taipei

11217

RECRUITING

Taipei Veterans General Hospital, Taipei

12203

RECRUITING

Charité - Universitätsmedizin Berlin (CBF) - Hindenburgdamm 30, Berlin

19107

RECRUITING

Thomas Jefferson University Research Facility, Philadelphia

28034

RECRUITING

Hospital Universitario Ramon y Cajal, Madrid

28644

RECRUITING

Chungbuk National University Hospital, Cheongju-si

29010

RECRUITING

Hospital Regional Universitario de Malaga - Hospital General, Málaga

31059

RECRUITING

Institut Claudius Regaud - PPDS, Toulouse

37203

RECRUITING

SCRI Oncology Partners - PPDS, Nashville

41013

RECRUITING

Hospital Universitario Virgen del Rocio, Seville

44115

RECRUITING

EDOG Institut de Cancerologie de l'Ouest - PPDS, Saint-Herblain

91010

RECRUITING

City of Hope, Duarte

92618

RECRUITING

City of Hope, Irvine

92648

RECRUITING

City of Hope, Huntington Beach

94800

RECRUITING

Gustave Roussy, Villejuif

28204-2990

RECRUITING

Levine Cancer Institute - Charlotte, Charlotte

84112-5550

RECRUITING

University of Utah - Huntsman Cancer Institute - PPDS, Salt Lake City

22031-2171

RECRUITING

NEXT Virginia, Fairfax

01307

RECRUITING

Universitätsklinikum Carl Gustav Carus an der TU Dresden, Dresden

Sponsors
All Listed Sponsors
lead

Antares Therapeutics, Inc

INDUSTRY

NCT06043817 - 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 | Biotech Hunter | Biotech Hunter