Simcha Therapeutics has dosed the first patient in a Phase I/II clinical trial of ST-067 along with KEYTRUDA (pembrolizumab) to treat advanced solid tumours.
The dose-escalation, open-label study will assess the decoy-resistant IL-18 agent ST-067 along with Merck (MSD)’s anti-PD-1 therapy KEYTRUDA in these patients.
Determining the maximum tolerated dose, preliminary activity, and recommended Phase II dose of the combined therapy is the study’s objective.
Other parameters, including safety, pharmacokinetics, pharmacodynamics and immunogenicity, are measured as secondary endpoints.
Simcha Therapeutics CEO Sanuj Ravindran said: “We have observed encouraging anti-tumour activity in preclinical studies combining our decoy-resistant IL-18 with PD-1 inhibitors, and we look forward to now studying this combination in the clinic.
“KEYTRUDA has become the standard of care for many cancer patients, and we believe adding ST-067 could further improve clinical outcomes.
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“This combination has the potential to become a powerful new therapeutic option for patients and physicians.”
The company’s lead programme ST-067 is assessed in trials as a single agent or combined with other anticancer agents.
ST-067 is also being studied as a monotherapy along with KEYTRUDA in Phase I/II clinical trials in solid tumour patients and those who have progressed on other immunotherapeutic agents.