X4 Pharmaceuticals, which developed X4P-001, presented the findings in a poster session at the European Society of Medical Oncology Congress in Madrid, Sept. 8-12. It was titled “A Phase 1 dose finding study of X4P-001 (an oral CXCR4 inhibitor) and axitinib in patients with advanced renal cell carcinoma (RCC).”
X4P-001 inhibits surface receptor CXCR4, a protein found at high levels in several types of cancer, including melanoma and ccRCC, a type of kidney cancer. Previous studies have shown a link between increased production of CXCR4 and lower cancer patient survival rates.
Researchers are evaluating X4P-001 as a potential treatment for both melanoma and refractory ccRCC.
The Phase 1/2 trial (NCT02667886), which is occurring at 13 centers in the United States, involves ccRCC patients. It is evaluating the safety and cancer-fighting potential of a combination of X4P-001 and Pfizer’s VEGFR inhibitor Inlyta, an approved second-line treatment option. The participants have received at least one previous line of therapy.
Sixteen patients have been enrolled in the Phase 1 part of the trial since April 2017. Researchers randomized them to receive escalating doses of X4P-001 and Inlyta. The X4P-001 doses are 200 mg twice a day, 400 mg once a day, or 600 mg once day. Inlyta is being administered twice a day.
Researchers have determined that the 400-mg dose of X4P-001 is the maximum tolerated, so it will be used in the Phase 2 part of the trial. The 600-mg dose led to moderate to severe adverse effects in two patients, including anorexia, cognitive problems, fatigue, nausea, vomiting, and sleepiness.
In general, the adverse events associated with X4p-001 have included diarrhea, hypertension, headache, difficulty speaking, protein in the urine, dry eye and mouth, joint pain, loss of taste, inflammation of mouth mucosa, and weight loss.
After a median of six months of treatment, researchers were able to assess nine patients for treatment response. Three achieved a partial response and five a stable disease, but the disease of one progressed.
“These data from our Phase 1/2 trial evaluating X4P-001-IO plus Inlyta in ccRCC contribute to our knowledge of the therapeutic potential of CXCR4 inhibition when combined with VEGFR inhibition,” Sudha Parasurman, X4’s chief medical officer, said in a press release. “These results demonstrate that the combination is well tolerated and demonstrates preliminary signs of clinical activity in a heavily pre-treated ccRCC patient population. We look forward to sharing updated data as our trial progresses.”
Researchers are still recruiting participants for the Phase 2 part of the study, which started in May 2017. It will evaluate the safety and effectiveness of X4P-001, both as a stand-alone therapy and in combination with Inlyta.
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?