Condition: Solid Tumours · Advanced Solid Tumours · Sponsor: Racura Oncology Ltd
This is a multi-centre, two-part, open-label, phase 1, first in human study of multiple ascending doses of RC220 bisantrene formulation alone and in combination with fixed dose doxorubicin to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) in adult patients with locally advanced unresectable or metastatic solid tumours where doxorubicin may be considered as a treatment option / or is indicated. The study will consist of two parts: Part 1 - This part involves a fixed-dose doxorubicin (60 mg/m2) tolerability lead-in period, followed by dose-escalating doses of IV RC220 alone, and in combination, with fixed dose doxorubicin, to determine the maximum tolerated combined dose (MTCD) of RC220 with doxorubicin to be evaluated in Part 2. This dose-expansion cohort will enrol patients with solid tumours that are anthracycline treatment naïve and for whom treatment with doxorubicin is indicated. The objective of Part 2 will be to confirm the safety and tolerability and evaluate the preliminary cardioprotective and anti-tumour efficacy of the maximum tolerated combined dose (MTCD) of RC220 with doxorubicin.
This description comes directly from the study's public registry record.
Marinella Messina · +61 480 258 306 · marinella.messina@racuraoncology.com
Corli Merry · corli.merry@racuraoncology.com
Always discuss trial participation with your own doctor first.
| Gosford Hospital | Gosford, New South Wales, Australia | Recruiting |
| Cancer Care Foundation | Miranda, New South Wales, Australia | Recruiting |
| Wyong Hospital | Wyong, New South Wales, Australia | Recruiting |
| Queen Mary Hospital | Hong Kong, Hong Kong | Recruiting |
| Prince of Wales Hospital | Shatin, Hong Kong | Recruiting |
| Asan Medical Centre | Seoul, South Korea | Not Yet Recruiting |
| Ewha Womans University MokDong Hospital | Seoul, South Korea | Not Yet Recruiting |
| Samsung Medical Centre | Seoul, South Korea | Not Yet Recruiting |
| Severance Hospital, Yonsei University, Health System | Seoul, South Korea | Not Yet Recruiting |
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT06815575