Zucero is pleased to announce that an amendment to an ongoing study entitled “An open-label, multi-centre Phase Ib study of the safety and tolerability of IV infused PG545 in combination with nivolumab in patients with advanced solid tumours with an expansion cohort in patients with metastatic pancreatic cancer” has been approved by the lead Human Research Ethics Committee (HREC), expanding the study to include patients with a particular form of bowel cancer known as microsatellite stable metastatic colorectal cancer (MSS mCRC).
The vast majority (90-95%) of bowel cancers are considered to be MSS mCRC and immune checkpoint inhibitors such as nivolumab (Opdivo®) have failed to show any clinical activity when used alone for this specific form of bowel cancer. However, early results from a phase Ib trial in a small group of patients with advanced cancer combining Opdivo® with Zucero’s pixatimod demonstrated evidence of immune system activation and indicated that patients with bowel cancer may benefit from the combination .
The clinical study is being performed by Scientia Clinical Research in collaboration with U.S. pharmaceutical company Bristol Myers Squibb who provided Opdivo®. Approval by the lead HREC was confirmed in July 2019, allowing recruitment of patients with MSS mCRC to the ZU545102 trial to commence immediately. The study is performed at five sites across Australia, Scientia Clinical Research based at the Prince of Wales Hospital (Sydney), Royal Adelaide Hospital (Adelaide), The Alfred Hospital (Melbourne), Royal Brisbane and Women’s Hospital (Brisbane), and Northern Cancer Institute (Sydney).
Zucero’s Chief Scientific Officer, Dr Keith Dredge, commented “We are committed to exploring whether pixatimod can overcome the inherent resistance to immune checkpoint inhibitors associated with MSS mCRC and are excited to support the coordinating investigator, Professor David Goldstein at the Prince of Wales Hospital, in further investigating this immunotherapy combination.”
The Phase Ib clinical trial will recruit up to 30 participants with MSS mCRC and continues to investigate the combination in pancreatic cancer. Information about the trial may be found here.
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