Trial | NCT02216409  Report issue

Title

Phase 1 Trial of Hu5F9-G4, a CD47-targeting Antibody
A First-in-Human Phase 1 Dose Escalation Trial of Hu5F9-G4 in Patients With Advanced Solid Malignancies

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    hu5f9-g4 ...

  • Study Participants

    88
The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in participants with solid tumors.
This is a first-in-human, first-in-class, escalating dose trial of an antibody that inhibits an anti-apoptotic signal in human macrophages. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.
Study Started
Aug 31
2014
Primary Completion
Oct 31
2018
Study Completion
Dec 31
2018
Last Update
Feb 05
2019

Drug Hu5F9-G4

Treatment (Hu5F9-G4) Experimental

Hu5F9-G4 monotherapy

Criteria 

Inclusion Criteria:

Patients with histologically or cytologically confirmed advanced solid malignancy or Lymphoma

Relapsed or refractory disease after at least 1 prior systemic treatment for the primary malignancy and not a candidate for other curative treatment.

Adequate hematologic status

Adequate coagulation function

Adequate hepatic function

Adequate renal function

Exclusion Criteria:

Known primary tumors of central nervous system disease

Known active brain metastases

Known cardiopulmonary disease
No Results Posted