The trial is evaluating the NDI-101150 monotherapy and along with pembrolizumab to treat advanced solid tumours. Credit: CI Photos / Shutterstock.com.

Nimbus Therapeutics has released positive results from the ongoing Phase I/II clinical trial of NDI-101150, an oral small-molecule hematopoietic progenitor kinase 1 (HPK1) inhibitor, for treating adults with advanced solid tumours.

The open-label, multicentre trial is evaluating NDI-101150 as a single agent at doses ranging from 50mg to 200mg, and with pembrolizumab to treat advanced solid tumours.

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The latest findings as of 18 March included data from 44 subjects in the dose escalation cohorts and further data from 15 patients in the dose expansion cohorts.

According to the results, 16.7% of response-evaluable patients experienced clinical benefits from the NDI-101150 monotherapy.

Notably, one patient with renal cell carcinoma (RCC) achieved a complete response, and another with RCC showed a partial response, despite previous treatments with multiple therapy lines including checkpoint inhibitors.

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Additionally, three subjects with RCC, pancreatic cancer, and endometrial cancer respectively, continued to have stable disease for over six months, with the RCC patient’s stable disease lasting 21 months.

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Among the RCC patient group, six out of eight showed the best overall response of stable disease or better.

NDI-101150 was found to be well-tolerated and its safety profile continues to be acceptable.

The latest findings were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting.

Nimbus Therapeutics chief medical officer Nathalie Franchimont said: “We are encouraged by these results being presented at ASCO and additional observations to date showing monotherapy clinical benefit and an acceptable safety profile of NDI-101150, further validating HPK1 as a differentiated next-generation immunotherapy target for people living with advanced solid tumours in need of new effective treatment options.

“NDI-101150 is a potent and highly selective HPK1 inhibitor that has the potential to achieve significant tumour growth inhibition and make a meaningful difference for patients.”