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September 19, 2018updated 12 Jul 2022 1:12pm

CBT Pharmaceuticals doses first patient in Phase l/ll trial of CBT-101

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.

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.

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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.

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.

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