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A Safety and Pharmacokinetics Study of RC220 Combined With Doxorubicin in Adult Participants With Solid Tumours.

ConditionsSolid TumoursAdvanced 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • RC220

    Drug

    The assigned dose will be administered by intravenous infusion over 60 minutes.

  • Doxorubicin (Adriamycin)

    Drug

    60 mg/m2 administered by intravenous infusion over 10 minutes on Day 1 of the monotherapy lead-in cycle (M1) and on Day 1 of each 21-day combination cycle following administration of intravenous RC220

Treatment groups

53 Participants
are divided into 2 treatment groups
Group A: Part 1: Dose EscalationExperimental treatment 2 interventions
Group B: Part 2: Dose ExpansionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part 1. Incidence of dose limiting toxicities (DLTs)

Evaluated at each dose level RC220 combined with doxorubicin, as graded by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0.

Time frame
During the first cycle of RC220 and doxorubicin treatment (1-21 days)
2

Part 1 and Part 2. Treatment emergent adverse events (TEAE) and serious adverse events (SAEs),

This includes clinically significant changes in vital signs, physical examination, electrocardiogram, echocardiogram and clinical laboratory tests, as graded by NCI CTCAE v5.0.

Time frame
First dose up to 30 days post last combination dose (up to 12 months)

Secondary outcomes

1

Part 1. Maximum tolerated combined dose (MTCD)

The MTCD is based on the incidence of Dose Limiting Toxicities (DLTs).

Time frame
After the first dose of RC220 and doxorubicin treatment cycle (1-21 days)
2

Part 1 and Part 2. Best Overall Response (BOR)

Percentage of patients with best confirmed overall response of clinical response (CR) or partial response (PR) (evaluated by the investigator according to RECISTv1.1) until the time of disease progression.

Time frame
Up to 12 months
3

Part 1 and Part 2. Duration of Response (DOR)

Defined as the time from the earliest date documented (CR or PR) (evaluated by the investigator according to RECISTv1.1) until disease progression or death (by any cause, in the absence of progression).

Time frame
Up to 12 months
4

Part 1 and Part 2. Progression Free Survival (PFS)

Defined as the time of first treatment until disease progression or death (by any cause, in the absence of progression).

Time frame
Up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Racura Oncology Ltd

Lead sponsor

Source ClinicalTrials.gov
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