Trial Profile

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer

Status: Recruiting

Phase of Trial: Phase I/II

Latest Information Update: 21 Sep 2025

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At a glance

Drugs Abemaciclib (Primary) ; Fulvestrant (Primary) ; INX 315 (Primary)
Indications Advanced breast cancer; Fallopian tube cancer; HER2 negative breast cancer; Ovarian cancer; Peritoneal cancer; Solid tumours
Focus Adverse reactions; First in man; Proof of concept; Therapeutic Use
Sponsors Incyclix Bio

25 Aug 2025 According to an Incyclix Bio media release, the company have secured $11.25 million extension to its Series B financing.The additional financing will advance this trial and completion of the study is on track for mid-2026. .
27 Apr 2025 Protocol amended to add Part C: HR+/HER2- BC Dose Expansion, INX-315 in combination with abemaciclib (oral administration) and fulvestrant added.
27 Apr 2025 Planned number of patients changed from 81 to 150.

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