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OncoMed begins Phase I trial of anti-RSPO3 antibody

OncoMed Pharmaceuticals has started dosing patients with advanced refractory solid tumors in its Phase Ia/Ib clinical trial of anti-RSPO3 antibody (OMP-131R10).

The company noted that 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.

In this open-label trial, which is being conducted at five sites in the US, patients will receive escalating doses of anti-RSPO3 until disease progression.

The trial is designed to evaluate 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 Ia expansion arm to secure additional preliminary information on possible anti-tumor activity.

In the Phase Ib portion of the trial, anti-RSPO3 will also be evaluated in second-line colorectal cancer patients in combination with the chemotherapeutic standard of care in metastatic colon cancer, known as Folfiri (folinic acid, fluorouracil and irinotecan).

OncoMed chief medical officer Jakob Dupont said: "The inhibition of RSPO3 has shown robust preclinical activity against a number of solid tumor types.

"In this trial, we look forward to establishing a suitable dose and exploring this antibody’s safety and initial efficacy.

"In addition, studies using our human tumor xenograft models have demonstrated a strong correlation between activity and RSPO3 biomarkers as well as potent activity in the colorectal cancer setting, which we will examine in the second part of this comprehensive PhaseIa/Ib trial."

The anti-RSPO3 antibody represents the third drug in the clinic that has been developed as part of OncoMed’s collaboration with Celgene.