Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

733

Participants

Timeline

Start Date

September 16, 2020

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2027

Conditions
Non Small Cell Lung CancerAdvanced Solid TumorMetastatic MelanomaMetastatic Head and Neck CarcinomaMetastatic Renal Cell CarcinomaMetastatic Colorectal CancerSarcomasMetastatic Prostate CancerOvarian CancerSmall Cell Lung CancerMetastatic Breast CancerPancreas CancerGastric CancerEsophageal CancerGastroesophageal Junction AdenocarcinomaCervical CancerAdenoid Cystic CarcinomaSalivary Gland CancerUrothelial Carcinoma
Interventions
DRUG

ONC-392

ONC-392 will be given by intravenous infusion, once every 21 days (Q3W). In Part C Arm M and in Part D, ONC-392 will be given Q4W.

DRUG

Pembrolizumab

Pembrolizumab will be given intravenous (IV) infusion at 200 mg/cycle, once every 21 days (Q3W).

DRUG

Docetaxel

Docetaxel will be given intravenous (IV) infusion at 75 mg/m2, once every 21 days (Q3W).

Trial Locations (37)

2305

Newcastle Private Hospital, New Lambton Heights

4120

Tasman Oncology Research, Southport

5000

Cancer Research SA, Adelaide

5042

Southern Oncology Clinical Research Unit, Bedford Park

10065

Memorial Sloan Kettering Cancer Center, New York

17325

Pennsylvania Cancer Specialists & Research Institute (Formerly Gettysburg Cancer Center), Gettysburg

20007

MedStar Georgetown University Hospital, Washington D.C.

20817

The Center for Cancer and Blood Disorders, Bethesda

21204

Greater Baltimore Medical Center, Baltimore

22031

NEXT/Virginia Cancer Specialists, Fairfax

29605

Prisma Health, Greenville

30322

Emory University Winship Cancer Institute, Atlanta

32610

University of Florida Health Cancer Center, Gainesville

32804

AdventHealth Cancer Institute, Orlando

33028

Memorial Cancer Institute, Pembroke Pines

33462

Florida Cancer Specialists, Atlantis

34474

Ocala Oncology Florida Cancer Affiliates, Ocala

37203

Tennessee Oncology - Nashville, Nashville

37404

Tennessee Oncology Chattanooga Memorial Plaza, Chattanooga

40202

Norton Health, Lexington

43210

The Ohio State University James Cancer Center, Columbus

43219

Zangmeister Cancer Center, Columbus

45219

University of Cincinnati Medical Center, Cincinnati

48109

University of Michigan Medical Center, Ann Arbor

72762

Highlands Oncology Group, Springdale

77030

Houston Methodist Cancer Center, Houston

Oncology Consultants, Houston

80045

University of Colorado Hospital, Aurora

84112

University of Utah Huntsman Cancer Institute, Salt Lake City

90241

The Oncology Institute of Hope and Innovation, Downey

91010

City of Hope Cancer Center, Duarte

95817

University of California at Davis, Davis

98109

University of Washington / Fred Hutchinson Cancer Center, Seattle

06856

Nuvance Health, Norwalk

02215

Dana Farber Cancer Institute, Boston

Massachusetts General Hospital, Boston

07960

Atlantic Healthcare System, Morristown

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

OncoC4, Inc.

INDUSTRY