Rondo Therapeutics begins dosing in Phase I/Ib trial for solid tumours

Rondo Therapeutics has initiated dosing in its Phase I/Ib clinical trial of first-in-class bispecific antibody, RNDO-564, targeting Cluster of Differentiation 28 (CD28) and Nectin-4 in advanced solid tumours.

The trial is intended for adults with relapsed or refractory locally advanced or metastatic urothelial carcinoma (mUC) and other solid tumours expressing Nectin-4.

RNDO-564 is designed to address the limitations of Nectin-4–targeting antibody-drug conjugates (ADCs), such as challenges with treatment-related toxicities and response durability that may necessitate treatment discontinuation or dose reductions.

The multi-centre, first-in-human, open-label study will assess the pharmacokinetics, tolerability, safety, and initial anti-tumour effects of RNDO-564.

It will investigate RNDO-564 both as a monotherapy and along with pembrolizumab in adults with refractory or relapsed locally advanced or mUC.

Preclinical findings showed that it elicited strong killing of Nectin-4-expressing tumour cells through both Nectin-4 and T-cell receptor-dependent mechanisms.

It inhibited tumour in vivo as a single agent and when combined with checkpoint therapy, restored the tumour cell killing ability of serially stimulated T cells in vitro, and retained cytotoxic effects in cells resistant to ADCs.

Rondo Therapeutics co-founder and CEO Shelley Force Aldred said: “We engineered RNDO-564 to deliver the widest therapeutic window through localised CD28 co-stimulation at the tumour site for safe and effective anti-tumour activity. The initiation of this trial marks an exciting milestone for Rondo as we advance our first co-stimulatory bispecific antibody into the clinic.”

Benjamin Garmezy, principal investigator of the RNDO-564-001 trial, said: “With the growing use of ADC/IO combinations, there remains a significant unmet need for patients whose disease relapses or who cannot tolerate these regimens. There is promise in developing new treatment options that can extend disease control and improve quality of life for these patients.”

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