A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRacura Oncology Ltd
About this trial
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.
Eligibility criteria
Qualifiers
Able to give voluntary informed consent and understand the study and are willing to follow and complete all the study required procedures.
Aged between 18 years to ≤ 80 years at the time of informed consent. Note: In Korea, only participants aged ≥19 years at the time of informed consent will be enrolled
Life expectancy ≥ 3 months.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Disqualifiers
Females who are pregnant or nursing.
Antitumour therapy (chemotherapy, antibody therapy, molecular targeted therapy, hormonal therapy or investigational agent) within 28 days prior to the first dose of study treatment (or 5 times the half-life if shorter than 28 days, there can be exceptions on a case-by-case as approved by Study Medical Monitor based on pharmacology). Note: concurrent use of hormone deprivation therapy for hormone-refractory prostate cancer, bisphosphonate or denosumab for skeletal related events per institution guideline is permitted.
Wide-field radiation therapy within 28 days (or palliative radiation therapy within 7 days) prior to the first dose of study treatment or has not recovered from the side effects of radiation therapy in the opinion of the Investigator.
Any other concurrent investigational device(s) or conventional agent(s) within 28 days (unless 5 times the half-life is shorter than 28 days) prior to the first dose of study treatment.
Trial design
Treatments tested in this trial
- RC220
- Doxorubicin (Adriamycin)
Treatment groups
53 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov