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Trial Summary

This is a First-in-Human Phase IA/IB/II open label dose escalation study of intravenous (IV) administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancers.

Acronym:

PRESERVE-001

ACTRN/NCT /ethics:

NCT04140526

Scientific title:

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

Sponsor / Cooperative group:

OncoC4, Inc.

Trial & Patient Characteristics

Cancer TypeSolid tumours; Non-small cell lung cancer
Trial TypeTreatment
PhasePhase I; Phase II
Age Range18 years and older
SexAll
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced; Metastatic or Widespread
Anticipated Start Date2020-09-16
Anticipated End Date2024-12-31

Participating Hospitals

HospitalSouthern Oncology Clinical Research Unit
Clinical Trial CoordinatorMeggan O'Riley
EmailMeggan.ORiley@socru.org.au
Phone0491 679 039
Principal InvestigatorDr Ganessan Kichenadasse
Recruitment StatusRecruiting
HospitalCancer Research SA
Clinical Trial CoordinatorKelly Mead/Kate Penta
Emailadmin@cancerresearchsa.com.au
Phone08 8359 2565
Principle InvestigatorDr Rohit Joshi
Recruitment StatusRecruiting