This is a Phase 1, First-in-Human, Multicentre, Open-label Study of RC118 for Injection in Patients with Locally Advanced Unresectable/Metastatic Solid Tumours to determine the safety and tolerability of RC118, including the maximum tolerated dose (MTD)/maximum administered dose (MAD), and to define the recommended Phase II dose (RP2D).
This is an open-label, Phase 1, FIH, study consisting of dose-escalation (Part A) and dose confirmation (Part B) in Australia. This trial is to evaluate the safety, tolerability (MTD/MAD), PK, immunogenicity of RC118, and further determine the RP2D. In addition, the preliminary anti-tumour efficacy of RC118 as single agent will be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
RC118 will be administered intravenously (IV) on Day 1 of every 14-day cycle.
Remegen Site #12
Macquarie Park, New South Wales, Australia
Remegen Site #14
Bedford Park, South Australia, Australia
Remegen Site #13
Frankston, Victoria, Australia
Remegen Site #11
Malvern, Victoria, Australia
MTD/MAD based on number of dose-limiting toxicities (DLTs)
The maximum tolerated dose (MTD)/maximum administered dose (MAD) will be assessed based on the number of patients experiencing DLTs, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0. If the MTD cannot be reached in this study, the MAD will be recorded.
Time frame: Up to 18 months
Determine Recommended Phase 2 Dose (RP2D)
The RP2D may be selected based on the MTD/MAD following consultation with the safety monitoring committee with all available data.
Time frame: Up to 18 months
Adverse Events
The adverse events occurring or worsening on or after the first dose of the study drug will be recorded.
Time frame: Up to 18 months
Object Response Rate (ORR)
ORR will be determined according to Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. The ORR is defined as the number of patients are either complete response (CR) or partial response (PR), relative to the number of patients belonging to the study of interest.
Time frame: Up to 18 months
Progression Free Survival (PFS)
PFS is defined as the time from the date of first administration to the date of the first documentation of progressive disease or death due to any cause, whichever occurs first.
Time frame: Up to 18 months
Disease Control Rate (DCR)
DCR is the proportion of patients with disease control.
Time frame: Up to 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Duration of response (DOR)
DOR is defined, for patients with response, as the time from first documentation of response (CR or PR) to the date of first documentation of progression of disease or death due to any causes whichever occurs first.
Time frame: Up to 18 months
Immunogenicity
Incidence of anti-drug antibody (ADA) against RC118
Time frame: Up to 18 months
Maximum Plasma Concentration [Cmax]
Cmax of total antibodies, RC118 and free MMAE
Time frame: Up to 18 months
Area under the plasma concentration [AUC]
AUC of total antibodies, RC118 and free MMAE
Time frame: Up to 18 months
Tmax
Peak time (Tmax) of total antibodies, RC118 and free MMAE
Time frame: Up to 18 months