In the trial, the median age of participants was 60 years. Credit: Andrei_R/Shutterstock.

Incyclix Bio has reported interim outcomes from the dose escalation part of the first-in-human, open-label Phase I/II INX-315-01 trial of INX-315 for the treatment of individuals with breast cancer.

This treatment is intended for subjects with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor-resistant oestrogen receptor-positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer or CCNE1-amplified solid tumours.

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INX-315-01 is a combination and dose-expansion trial designed to evaluate INX-315’s tolerability, safety, pharmacokinetics, and preliminary antitumor activity in subjects with recurrent advanced/metastatic cancer.

As a single agent, it was found to be well-tolerated and safe among 31 subjects.

Notably, there was only one instance of dose-limiting toxicity and no subjects discontinued treatment due to adverse events.

The antitumor activity of the therapy was particularly noteworthy in heavily pretreated subjects. Among those evaluated for response, 10% achieved a partial response (PR), and 63% maintained stable disease (SD).

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Breaking it down further, in subjects with ER+/HER2- breast cancer, 10% experienced PR and 50% had SD. In subjects with CCNE1-amplified high-grade serous ovarian cancer (HGSOC)/fallopian, 20% achieved PR and 80% had SD.

The antitumor activity and monotherapy safety profile of the therapy support its continued investigation. The data suggests its potential as a single agent in treating CCNE1-amplified solid tumours and in conjunction with standard care therapies for ER+/HER2- breast cancer.

The median age of participants was 60 years, with a range of 29 to 78 years, with 74% being female subjects. Tumours studied included ER+/HER2- breast cancer, HGSOC, and other solid tumours.

Subjects had undergone a median of four prior lines of therapy.

The trial’s monotherapy and combination dose-expansion phases are currently ongoing.

Incyclix Bio CEO and co-founder Patrick Roberts said: “We are excited to unveil these compelling data, which underscore the safety, tolerability, and encouraging antitumour activity of our CDK2 inhibitor, INX-315, in heavily pretreated patients with advanced, treatment-resistant breast and ovarian cancers.

“Sharing these results with leading oncologists at SABCS is a significant milestone. This progress reinforces the best-in-class potential of INX-315 and brings us closer to delivering a transformative treatment option for patients facing some of the most challenging cancer diagnoses.”