Up to 18 subjects with unresectable, metastatic liposarcoma or leiomyosarcoma will be enrolled in the expansion cohort. Credit: Volha_R / Shutterstock.

US-based biotechnology company Sonnet BioTherapeutics has expanded its Phase I SB101 study of SON-1010 for advanced solid tumours.

The company is adding a cohort to assess the efficacy of SON-1010 when it is given in combination with trabectedin (Yondelis).

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The decision follows the completion of monotherapy dose escalation for SON-1010, also known as IL12-FHAB, in adults with advanced solid tumours.

It aims to explore the therapy’s immune-oncology impact at the maximum tolerated dose (MTD) of 1,200ng/kg in combination with trabectedin, a chemotherapeutic drug approved for certain advanced soft-tissue sarcomas (STS).

Sonnet said this combination could potentially improve the local immune response within the tumour microenvironment.

The company has begun enrolling subjects in the new cohort, with enrolment due to be complete in the first half of this year and topline safety data expected in the second half.

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In this cohort, up to 18 subjects with unresectable, metastatic liposarcoma or leiomyosarcoma will be treated with SON-1010 in combination with standard 21-day trabectedin cycles.

The SB101 trial’s primary outcomes include assessing the therapy’s tolerability, pharmacokinetics, safety and pharmacodynamics, as well as establishing the MTD.

Sonnet founder and CEO Pankaj Mohan said: “The Sonnet team has been studying the efficacy and safety of SON-1010 as a single agent, which has thus far suggested clinical benefit when administered as a monotherapy in patients with advanced solid tumours.

“Further, we believe this synergy could improve the response in a serious type of cancer at an earlier stage of disease, which could open up another potential opportunity for partnering.”

The expansion cohort results are expected to position SON-1010 for a Phase II study, potentially establishing its combination with trabectedin as a new and improved treatment for STS.

Sonnet BioTherapeutics is also evaluating the therapy in a Phase Ib/IIa dose-escalation and proof-of-concept study, SB221, in combination with atezolizumab (Tecentriq) for platinum-resistant ovarian cancer.