Solid Tumor
Conditions
Brief summary
The purpose of this study is to assess the safety and tolerability of Hu5F9-G4 in participants with solid tumors.
Detailed description
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.
Interventions
DRUGHu5F9-G4
Sponsors
Gilead Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of Hu5F9-G4 | The first 28 days on study, for determination of Dose Limiting Toxicities | The CTCAE criteria will be used to assess adverse events on this trial. |
Countries
United States
Outcome results
None listed