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January 17, 2014
08:36 EDTOMEDOncoMed presents data from Phase 1b clinical trial of demcizumab
OncoMed presented data from its ongoing Phase 1b clinical trial of demcizumab in first-line Stage IV pancreatic cancer patients. Demcizumab was generally well tolerated in combination with both gemcitabine and Abraxane with fatigue, hypertension, nausea and vomiting being the most common drug-related toxicities. No demcizumab-related reversible cardiotoxicity events have occurred with the implementation of regular monitoring, a truncated treatment approach and cardioprotective medication, if indicated. The combination of gemcitabine with or without Abraxane did not appear to influence the pharmacokinetics of demcizumab. 50% evaluable patients who received the demcizumab/gemcitabine/Abraxane combination had partial responses as measured by RECIST and two patients had stable disease resulting in a clinical benefit rate of 83%. A randomized Phase 2 clinical trial in patients with first-line pancreatic cancer is planned for the second half of 2014.
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July 28, 2015
08:51 EDTOMEDOncoMed initiates Phase 1 clinical trial for Anti-RSPO3 antibody
OncoMed Pharmaceuticals announced dosing of the first patient in its anti-RSPO3 antibody Phase 1a/1b clinical trial. Anti-RSPO3 is the first drug in its class to target the R-spondin-LGR pathway, an important cancer stem cell pathway identified by OncoMed researchers. The Phase 1a/1b clinical trial is initially enrolling patients with advanced refractory solid tumors. Patients will receive escalating doses of anti-RSPO3 until disease progression. The open-label study is designed to assess the safety, pharmacokinetics, pharmacodynamics and initial evidence of efficacy of the anti-RSPO3 antibody. Once a single-agent dose has been identified, biomarker-selected patients will be enrolled in a Phase 1a expansion arm to obtain additional preliminary information on possible anti-tumor activity. In the Phase 1b portion of the trial, anti-RSPO3 will also be tested in second-line colorectal cancer patients in combination with the chemotherapeutic standard of care in metastatic colon cancer, known as FOLFIRI. The trial is being conducted at five sites in the United States.

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