A Phase 1b Study of Gemcitabine Plus OMP-21M18 as 1st-line Treatment in Subjects With Locally Advanced or Metastatic Pancreatic Cancer
Current cancer therapies often produce an initial reduction in tumour size but may not have
longterm benefits. One possible explanation for this is the presence cancer cell known as a
cancer stem cells. Cancer stem cells represent a small part of the tumour but are believed
to be responsible for much of the growth and spread of the cancer. They may also be more
resistant to traditional therapy, such as chemotherapy and radiation therapy.
The purpose of this study is to test the safety and determine the optimal dose of a new
experimental drug, OMP-21M18, when given in combination with gemcitabine, a drug that is a
standard treatment for advanced pancreatic cancer that has not been treated previously with
chemotherapy. OMP-21M18 is a humanized monoclonal antibody (a protein made in the
laboratory) and was developed to target cancer stem cells. The way the body handles
OMP-21M18 will also be investigated.
Up to 40 participants, 21 years or older, will be enrolled at up to 6 centres in Australia,
New Zealand and Spain. Following informed consent and screening, participants will receive
intravenous infusions of OMP-21M18 every 28 days and Gemcitabine administered weekly for the
first 7 weeks. After 9 weeks, participants will undergo assessments to determine their
disease status. Participants will continue to receive infusions of OMP-21M18 every 28 days
and gemcitabine once weekly for 7 weeks follow by a week rest from treatment until disease
progression. A Data Safety Monitoring Board (DSMB) will review the data for the 6
participants at each dose level after the last participant in that group has been treated
for 56 days and decide whether it is safe to move up to the next highest dose level. After
confirming the optimum dose, 14 additional participants will be treated at the highest dose
level that the DSMB considers safe.
Participants will be assessed for disease status every 8 weeks and for safety at every visit
and for 30 days after the end of study drug treatment. Safety will be assessed by adverse
event monitoring, physical examination, vital signs, blood tests, cardiac monitoring, and
participant interview. Response rates, duration of response, time to progression, and
survival will be evaluated, requiring CT or MRI scans and CA199 (tumour marker) levels at
baseline and then every 8 weeks. The development of antibodies to treatment will be assessed
throughout the study and up to 12 weeks after the end of study drug treatment. Blood samples
will be taken to assess whether OMP-21M18 is producing desired changes to the genes and
proteins related to the cancer (biomarkers).
The study includes an optional part which will investigate how variations in people's
genetic makeup affect their response to medications. This involves the collection of one
blood sample just before participants receive their first dose of study treatment. DNA will
be extracted from the blood sample for testing.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- To determine the maximum tolerated dose of OMP-21M18 when combined with gemcitabine
Until disease progression
Australia: Department of Health and Ageing Therapeutic Goods Administration