Sweden-based Oncorena has successfully treated its first renal cancer patient with ONC175 in a Phase I/II trial.

The company announced the milestone one month after the treatment was conducted at the Center for Clinical Cancer Studies at Karolinska University Hospital, Sweden.

Oncorena plans to treat additional patients with ONC175 later this year.

ONC175 is being developed as a selective organ-targeted chemotherapy with potential curative effects in metastatic renal cancer patients. The drug candidate is a synthetically produced orellanine of the Cortinarius mushroom family.

Principal investigator Dr Jeffrey Yachnin said: “It concerns a very different and unique medicine that is being tested here on patients with disseminated kidney cancer. We are very happy that the study is underway and we look forward to the results.”

According to the ClinicalTrials.gov registry, the study completion is expected in August 2025.

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Phase I/II trial design

The Phase I/II trial (NCT05287945) is enrolling up to 40 patients with metastatic clear-cell or papillary renal carcinoma who are on dialysis.

This open-label, non-controlled study aims to evaluate the safety, tolerability and anti-tumour efficacy of ONC175. Each patient will receive haemodialysis after the infusion.

The trial consists of two parts that include an intra-patient dose escalation phase, which will be followed by a dose expansion portion. The first part is designed to define the maximum tolerated dose using a 3+3 design or dose-producing complete response in two or more patients.

This will enable the subsequent portion of the trial to measure safety and efficacy in a more standardised manner, according to the ClinicalTrials.gov registry.

An independent data review committee will review pharmacokinetics, safety and tolerability data after each dose in every patient and recommend potential dose escalations.

In addition to the trial site in Sweden, the study might include patients from other countries. Oncorena first announced its plans for the Phase I/II trial in February 2022.

Renal cancer landscape

Renal cell carcinoma (RCC) accounts for around 3% of all cancers, with the highest prevalence in Western countries, according to the European Association of Urology. In 2022, nearly 180,000 people died from RCC worldwide.

Recently, Merck (MSD) has reported that its Phase III trial in RCC has met the primary endpoint of progression-free survival (PFS). The study investigated a 120mg dose of WELIREG, an oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor.

At the beginning of August, the US Food and Drug Administration (FDA) granted a fast track designation to Invectys’ CAR-T therapy IVS-3001 for the treatment of RCC.