Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

333

Participants

Timeline

Start Date

December 10, 2019

Primary Completion Date

October 30, 2026

Study Completion Date

May 12, 2027

Conditions
Solid TumorNon-Small Cell Lung CancerHead and Neck CancerMelanomaGastric CancerRenal Cell CarcinomaUrothelial Carcinoma
Interventions
DRUG

INBRX-106 - Hexavalent OX40 agonist antibody

The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).

DRUG

pembrolizumab 200 mg

pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.

DRUG

pembrolizumab 400 mg

pembrolizumab 400 mg by IV infusion given on Day 1 of alternating 21-day cycles (every 6 weeks)

DRUG

Carboplatin AUC-5

carboplatin AUC-5 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4

DRUG

Carboplatin AUC-6

carboplatin AUC-6 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4

DRUG

Pemetrexed 500 mg/m2

pemetrexed 500 mg/m2 by IV infusion given on Day 1 of each 21-Day cycle for up to 35 cycles

DRUG

Cisplatin 75mg/m2

cisplatin 75mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4

DRUG

Paclitaxel 200mg/m2

paclitaxel 200mg/m2 by intravenous (IV) infusion, given on Day 1 of each 21-day cycle of cycles 1-4

DRUG

Nab paclitaxel 100mg/m2

Nab paclitaxel 100mg/m2 by intravenous (IV) infusion, given on Days 1, 8 and 15 of each 21-day cycle of cycles 1-4

Trial Locations (42)

10467

RECRUITING

Montefiore Medical Center, The Bronx

22031

RECRUITING

Virginia Cancer Specialists, Fairfax

30322

RECRUITING

Winship Cancer Institute - Emory University, Atlanta

32763

RECRUITING

Mid Florida Hematology and Oncology Center, Orange City

34711

RECRUITING

Clermont Oncology Center, Clermont

37204

RECRUITING

Vanderbilt University School of Medicine, Nashville

40202

RECRUITING

Norton Cancer Institute, Louisville

44195

RECRUITING

Cleveland Clinic, Cleveland

48201

RECRUITING

Barbara Ann Karmanos Cancer Institute, Detroit

48202

RECRUITING

Henry Ford Cancer Institute, Detroit

49546

RECRUITING

START Midwest, Grand Rapids

52242

RECRUITING

University of Iowa, Iowa City

53226

RECRUITING

Froedtert Hospital and the Medical College of Wisconsin, Milwaukee

55101

RECRUITING

HealthPartners Cancer Research Center (Regions Hospital), Saint Paul

55426

RECRUITING

HealthPartners Cancer Research Center, Saint Louis Park

59102

RECRUITING

Intermountain Health Cancer Centers of Montana, Billings

60637

RECRUITING

The University of Chicago Medical Center, Chicago

68130

RECRUITING

Nebraska Cancer Specialists, Omaha

75230

RECRUITING

Mary Crowley Cancer Research, Dallas

75701

RECRUITING

The University of Texas Health Science Center at Tyler, Tyler

77380

COMPLETED

Renovatio Clinical, The Woodlands

78229

COMPLETED

NEXT Oncology, San Antonio

79915

COMPLETED

Renovatio Clinical - El Paso, El Paso

90027

RECRUITING

California Research Institute, Los Angeles

90069

RECRUITING

Valkyrie Clinical Trials, Los Angeles

91010

RECRUITING

City of Hope, Duarte

91204

RECRUITING

Los Angeles Cancer Network, Glendale

92562

RECRUITING

Valkyrie Clinical Trials, Murrieta

95403

RECRUITING

Providence Medical Foundation, Santa Rosa

97213

RECRUITING

Providence Portland Medical Center, Portland

Unknown

RECRUITING

Curie Oncology, Singapore

RECRUITING

Icon Cancer Centre Farrer Park, Singapore

RECRUITING

Icon Cancer Centre Mount Alvernia, Singapore

RECRUITING

The Catholic University of Korea, St. Vincent's Hospital, Gyeonggi-do

RECRUITING

Asan Medical Center, Seoul

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

RECRUITING

The Catholic University of Korea Seoul St. Mary's Hospital,, Seoul

RECRUITING

Changhua Christian Hospital (CCH), Changhua

RECRUITING

E-Da Cancer Hospital, Kaohsiung City

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH), Kaohsiung City

RECRUITING

National Cheng Kung University Hospital, Tainan City

RECRUITING

Taipei Veterans General Hospital, Taipei

Sponsors
All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Inhibrx Biosciences, Inc

INDUSTRY

NCT04198766 - Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist) | Biotech Hunter | Biotech Hunter