Solid Cancers
Conditions
Keywords
Solid Tumor, Cancer
Brief summary
This is a Phase I, first-in-human, open-label, dose-escalation study of MEGF0444A administered by IV infusion to patients with advanced solid tumors for whom standard therapy either does not exist or has proven to be ineffective or intolerable.
Interventions
DRUGMEGF0444A
Intravenous escalating dose
Sponsors
Genentech, Inc.
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
* Histologically or cytologically documented, incurable, or metastatic solid malignancy that has progressed on, or failed to respond to regimens or therapies known to provide clinical benefit
Exclusion criteria
* Inadequate hematologic and organ function * Anti-cancer therapy within 4 weeks prior to initiation of study treatment * Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1, except for alopecia * Active infection or autoimmune disease * Pregnancy (positive pregnancy test) or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, nature, relatedness, and severity of adverse events | Day 1 to study completion |
| Incidence and nature of dose-limiting toxicities (DLTs) | Days 1-21 of cycle 1 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters including total exposure, minimum and maximum serum concentration, clearance, and volume of distribution | Following administration of study drug |
Outcome results
None listed