US-based biotechnology firm X4 Pharmaceuticals has begun the Phase II portion of its ongoing Phase I/II clinical trial with dosing of X4P-001 in combination with Inlyta (axitinib) in advanced clear cell renal cell carcinoma (ccRCC) patients.
X4P-001 is an oral, small molecule inhibitor of C-X-C receptor type 4 (CXCR4), a receptor for the chemokine CXCL12, while Inlyta is an inhibitor VEGF kinase.
The primary receptor-ligand pairing of CXCR4/CXCL12 is reportedly used by cancer and surrounding stromal cells to inhibit immune function and promote angiogenesis.
The Phase II part of the Phase I/II trial will assess the safety, tolerability, objective response rate (ORR), duration of response (DOR) and progression-free survival (PFS).
The trial is currently being conducted at various sites in the US and South Korea, and will also evaluate the correlation between biomarkers and efficacy.
X4 Pharmaceuticals chief medical officer Sudha Parasuraman said: “Efficiently progressing this study into Phase II is an important milestone for the development of X4P-001 and the CXCR4-targeted therapeutic approach.
“Having established the Phase II combination dose of X4P-001, we are now focused on augmenting proof-of-concept data for this critically important biological axis known to play a key role in immune cell trafficking.”
X4P-001 is being further studied as a combination therapy to treat various types of cancer, based on data from pre-clinical studies.
Another Phase I/II trial is currently evaluating the drug in combination with Opdivo (nivolumab) for the treatment of patients with advanced ccRCC, while a Phase Ib biomarker trial is assessing it in combination with Keytruda (pembrolizumab) in advanced melanoma patients.
Image: Micrograph of a clear cell renal cell carcinoma. Photo: courtesy of nephron.