Hepatocellular carcinoma in an individual who was hepatitis C positive. Credit: Ed Uthman.

CBT Pharmaceuticals has dosed the first patient in a Phase l/ll trial of CBT-101 in combination with an anti PD-1 cancer immunotherapy CBT-501 for the treatment of locally advanced or metastatic disease.

The trial is the initial study of the APOLLO series of oncology clinical trials programme carried out by CBT to examine whether CBT-101 can work in combination with other agents to improve single agent immunotherapy response rates, and, ultimately, to treat patients with cancer.

CBT Pharmaceuticals co-founder and president Sanjeev Redkar said: “Initiating our APOLLO Oncology Clinical Trials Programme and dosing the first patient is a major milestone for CBT as we advance our mission to improve the lives of cancer patients through combination treatment regimens.”

The newly initiated Phase l/ll trial is an open-label, multi-centre, dose-escalation and expansion study that comprises two arms.

“The newly initiated Phase l/ll trial is an open-label, multi-centre, dose-escalation and expansion study that comprises two arms.”

Each of the study arms will investigate CBT-101 with CBT-501 in hepatocellular carcinoma (HCC), or CBT-101 and Bristol-Myers Squibb Company’s nivolumab (OPDIVO) in renal cell carcinoma (RCC), respectively.

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CBT-101 is CBT’s proprietary c-Met inhibitor that targets the epithelial to mesenchymal transition (EMT) pathway, while CBT-501 is the company’s IgG4 humanised monoclonal antibody against the PD-1 membrane receptor on immune cells.

The primary endpoint of the study’s Phase l portion is to determine any dose-limiting toxicities, as well as evaluate overall safety and tolerability of CBT-101 and CBT-501 for HCC and CBT-101, and nivolumab for RCC.

The primary endpoint of the Phase ll portion is to analyse preliminary efficacy by objective response rate (ORR) and duration of response (DOR) per irRECIST (Immune-related Response Evaluation Criteria In Solid Tumours).

Its secondary endpoints are establishing the recommended Phase ll dose, determination of the pharmacokinetic (PK) parameters of CBT-101 and CBT-501 when administered in combination, among others.