A Phase Ib Study of Fractionated 90Y-hPAM4 with or without Gemcitabine in Patients with Metastatic Pancreatic Cancer who Received at Least Two Prior Treatments
Study Status
Closed to Enrollment
Study Description
This clinical trial is for men and women with advanced pancreatic cancer which their doctors feel cannot be cured by surgry.
Standard treatments for pancreatic cancer may use gemcitabine or other forms of chemotherapy or, in some cases, external radiation. This may slow the cancer in some people, but for most people the cancer will continue to worsen.
This study is researching a new antibody called hPAM4. Antibodies are proteins normally made by the immune system; they bind to substances that don’t belong in the body or to prevent harm to the body. hPAM4 antibodies were designed to bind to the pancreatic cancer. For treatment, the hPAM4 antibodies are attached to a radioactive isotope called 90yttrium (the combination is called 90Y-hPAM4). The strategy is that the hPAM4 will bind to the pancreatic cancer, and then the radioactive 90Y will target the tumors.
The purpose of the study is to test the safety of different doses of 90Y-hPAM4 by itself or combined with gemcitabine. In addition, the study will evaluate the effects of 90Y-hPAM4 on advanced pancreatic cancer.
There are 2 arms in the study:
- Arm 1: 90Y-hPAM4 + Gemcitabine: the treatment cycle is 4 weeks, gemcitabine once weekly for 4 weeks and 90Y-hPAM4 once weekly for the last 3 weeks
- Arm 2: 90Y-hPAM4 Only: the treatment cycle is 3 weeks; participants receive 90Y-hPAM4 once weekly for 3 weeks
Study participants will be entered into the study arms in alternating order, with no special preference. Participants will receive the drugs over repeated treatment cycles, with a goal of completing at least 2 cycles. After completion of treatment, participants will be asked to return for long-term follow up for up to 2 years.
Study participants will be asked to complete pain assessment forms and pain medication diaries while participating in the study. Participants will receive $50 every time they return the completed pain assessment forms and pain medication diaries.
Disease Status and/or Stage
Stage IV Metastatic Pancreatic Cancer
Sponsor
Immunomedics
Key Eligibility
- Men and women age 18 and older
- Stage IV metastatic pancreatic cancer
- Previously treated and received at least 2 prior chemotherapy regimens for advanced disease
- Detailed eligibility reviewed when you contact the study team
Principal Investigator
Contact
- Alice Mercado, RN
- (212) 746-5430
- [email protected]
- GI Oncology Medical Practice
- (646) 962-6200
Protocol ID
IM-T-hPAM4-03
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Contact Us
For general inquiries, or if you need assistance finding a study, please contact:
Erica Bersin
Tel: (646) 962-8232
[email protected]
