Advanced Malignancy, Advanced Solid Tumors, Cancer, Solid Tumors, Tumors
Conditions
Keywords
Advanced Solid Tumors, AMG 479, Amgen, Oncology, Phase 1b
Brief summary
To assess the safety, tolerability, and pharmacokinetic profiles of AMG 479 when used in combination with bevacizumab, sorafenib, panitumumab, erlotinib, or gemcitabine in subjects with advanced solid tumors. Up to 126 subjects may be enrolled. Sorafenib and erlotinib combo cohorts are enrolling. All other combo cohorts are closed to enrollment.
Interventions
DRUGAMG 479
AMG 479 is a fully human IgG1 monoclonal antibody that inhibits IGF-1R signalling. AMG 479 (6mg/kg or 12mg/kg) will be given IV every 2 weeks in combination with sorafenib (400 mg po BID) or erlotinib (150 mg po QD).
Sponsors
NantCell, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form * Men and women ≥ 18 years old with a pathologically or cytologically documented, advanced solid tumor that is refractory to at least one line of therapy or for whom no standard therapy is available and for which no curative therapy is available, or the subject refuses standard non-curative therapy * Measurable disease or evaluable disease per World Health Organization (WHO) guidelines * Eastern Cooperative Oncology Group performance status ≤ 2 * Life expectancy of 3 months as documented by the investigator * Adequate hematologic, renal and hepatic function
Exclusion criteria
* Any co-morbid medical condition that would increase the risk of toxicity in the opinion of Investigator or Sponsor * Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade 0 or 1, or to levels dictated in the inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the safety, tolerability, and pharmacokinetic profiles of AMG 479 when used in combination with bevacizumab, sorafenib, panitumumab, erlotinib or gemcitabine in subjects with advanced solid tumors | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate pharmacokinetic (PK) profiles of biologics or chemotherapy when used in combination with AMG 479 | 3 years |
| To evaluate tumor response as assessed by World Health Organization (WHO) criteria | 3 years |
| To evaluate tumor response as measured by volumetric computed tomography (CT) | 3 years |
| To evaluate anti-AMG 479 antibody response following AMG 479 administration | 3 years |
Outcome results
None listed