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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04914117


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT04914117
Ethics application status
Date submitted
21/05/2021
Date registered
4/06/2021

Titles & IDs
Public title
A Study of RC118 in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours
Scientific title
Phase 1, First-in-Human, Multicentre, Open-label Study of RC118 for Injection in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours
Secondary ID [1] 0 0
RC118G001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable Solid Tumor 0 0
Metastatic Solid Tumor 0 0
Locally Advanced Solid Tumor 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - RC118 for injection

Experimental: RC118 for injection - Part A (Dose Escalation): RC118 will be administered through IV infusion at the various dose levels, including 0.25, 0.5, 1.0, 1.5, 2, 2.5, and 3 mg/kg, 1-12 subjects for each dose level.

Part B (Dose Confirmation): RC118 will be administered at up to two dose levels, which is equal or lower than MTD/MAD, through IV infusion. Each dose level contains 3-6 subjects.


Treatment: Drugs: RC118 for injection
RC118 will be administered intravenously (IV) on Day 1 of every 14-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
MTD/MAD based on number of dose-limiting toxicities (DLTs)
Timepoint [1] 0 0
Up to 18 months
Primary outcome [2] 0 0
Determine Recommended Phase 2 Dose (RP2D)
Timepoint [2] 0 0
Up to 18 months
Primary outcome [3] 0 0
Adverse Events
Timepoint [3] 0 0
Up to 18 months
Secondary outcome [1] 0 0
Object Response Rate (ORR)
Timepoint [1] 0 0
Up to 18 months
Secondary outcome [2] 0 0
Progression Free Survival (PFS)
Timepoint [2] 0 0
Up to 18 months
Secondary outcome [3] 0 0
Disease Control Rate (DCR)
Timepoint [3] 0 0
Up to 18 months
Secondary outcome [4] 0 0
Duration of response (DOR)
Timepoint [4] 0 0
Up to 18 months
Secondary outcome [5] 0 0
Immunogenicity
Timepoint [5] 0 0
Up to 18 months
Secondary outcome [6] 0 0
Maximum Plasma Concentration [Cmax]
Timepoint [6] 0 0
Up to 18 months
Secondary outcome [7] 0 0
Area under the plasma concentration [AUC]
Timepoint [7] 0 0
Up to 18 months
Secondary outcome [8] 0 0
Tmax
Timepoint [8] 0 0
Up to 18 months

Eligibility
Key inclusion criteria
1. Patients must be able to provide documented voluntary informed consent.
2. Male or female patient = 18 years and = 75 years.
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0 or 1.
4. The expected survival period exceeds 12 weeks.
5. At least one target lesion that can be measured per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
6. Histologically documented, incurable, unresectable locally advanced or metastatic tumours that are intolerable or refractory to standard therapies.
7. Patients agree to provide pre-treatment archived /biopsy tumour samples for retrospective Claudin 18.2 test. Archival tumour tissue should be from the most recent timepoint before entering the trial. In addition, archived samples obtained out of the screening are acceptable if it is discussed and approved by the Investigator and Sponsor in advance. Only when archived samples cannot be obtained, the biopsy will be considered at screening. Fresh tumour biopsies will NOT be considered if significant risk procedures are required with the discretion of Investigator.
8. Adequate bone marrow, liver, and renal function defined as: absolute neutrophil count (ANC) = 1.5 × 109/L, platelet = 100 × 109/L, haemoglobin = 90 g/L, serum total bilirubin = 1.5 × upper limit of normal (ULN), ALT, AST or ALP = 2.5 × ULN (= 5 × ULN when there is known liver metastasis), serum creatinine = 1.5 × ULN, INR = 1.5 × ULN, APTT = 1.5 × ULN.
9. Willingness to avoid pregnancy or fathering children based on the criteria below:

* Female patients of childbearing potential and male patients with partners of childbearing potential treated with RC118, must agree to use a highly effective form(s) of contraception during study and within 6 months after the last dose. Those methods include but not limited to combined (oestrogen and progestogen containing) hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion or vasectomized partner (on the understanding that this is the only one partner during the whole study duration), and sexual abstinence.
* Females of non-childbearing potential (e.g., surgically sterile with a hysterectomy and/or bilateral oophorectomy or chemically sterile or = 12 months of amenorrhea in the absence of chemotherapy, anti-oestrogens, or ovarian suppression). Those females do not need to undergo pregnancy test.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are pregnant or breastfeeding.
2. Diagnosed active hepatitis B infection (defined as positive of hepatitis B surface Ag and hepatitis B DNA=500IU/ml), active hepatitis C infection (defined as presence of hepatitis C RNA), and human immunodeficiency virus infection (defined as positive HIV test) during the screening period.
3. Received vaccines within 4 weeks prior to administration or plan on receiving any vaccine during the study.
4. Subjects with a history of other acquired/congenital immunodeficiency diseases or organ transplantation.
5. Patients have history of targeted therapy of Claudins, or participated in other clinical trials and received investigational product within 4 weeks before the first administration of study drug.
6. Allergic constitution or allergic to known research drug active ingredients or excipient.
7. Patients who are under the treatment of anticoagulant drugs (e.g., warfarin, apixaban, and heparin). Patients using prophylactic doses of heparin (e.g., LMWH) is eligible in the study.
8. Patients undergoing any anti-tumour therapy, including surgery, chemotherapy, radiotherapy and biological therapy, within 4 weeks prior to the first administration of study drug, or palliative radiotherapy for bone/other solitary metastases within 2 weeks prior to the first administration of study drug.
9. Previous adverse reactions resulting from previous anti-tumour therapies, which have not returned to Grade 0 or 1 according to NCI-CTCAE v5.0 (except alopecia) at screening.
10. There are clinical symptoms of fluid in the third space (e.g., large amounts of pleural fluid or ascites) that cannot be controlled by drainage or other therapies.
11. A clinically significant active infection judged by the investigator.
12. Comorbidities that may seriously endanger the patient's safety or affect the completion of the study, such as gastrointestinal bleeding (within 4 weeks prior to the screening period), peptic ulcer, intestinal obstruction, intestinal paralysis, interstitial pneumonia, pulmonary fibrosis, kidney failure, and uncontrolled diabetes.
13. QTc interval > 480 ms in both male and female (based on the mean value of the triplicate screening ECGs); family or personal history of long/short QT syndrome, History of ventricular arrhythmia deemed clinically significant by the investigator, or currently receiving antiarrhythmic drug treatment, or implantation of arrhythmia defibrillation device.
14. History of myocardial infarction within 6 months prior to the screening period, severe or unstable angina pectoris, coronary or peripheral artery bypass grafting, heart failure = 3 (New York Heart Association), or uncontrolled hypertension.
15. Patients with known current alcohol dependence or drug abuse.
16. Patients with a long-term history of systemic steroid therapy. Patients with short-term (= 7 days) use and drug withdrawal > 2 weeks are eligible.
17. History or presence of uncontrolled primary brain tumours (e.g., leptomeningeal carcinomatosis) or metastatic brain tumours, unless considered stable by the Investigator and local therapy was completed.
18. History or presence of Grade = 2 peripheral neuropathy.
19. History or presence of uncontrolled mental illness at the discretion of the Investigator, which may place the participant at increased risk of safety/tolerability issues.
20. The patient is, in the opinion of the investigator, expected to be non-compliant with critical trial procedures and is not willing or able to adhere to the trial requirements in the future.
21. Patients who are not appropriate for this clinical trial at the discretion of the investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/03/2023
Sample size
Target
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Remegen Site #12 - Macquarie Park
Recruitment hospital [2] 0 0
Remegen Site #14 - Bedford Park
Recruitment hospital [3] 0 0
Remegen Site #13 - Frankston
Recruitment hospital [4] 0 0
Remegen Site #11 - Malvern
Recruitment postcode(s) [1] 0 0
2109 - Macquarie Park
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3144 - Malvern

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
RemeGen Co., Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04914117

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 14
Cabrini Hospital - Malvern
Recruitment hospital [2] 15
Macquarie University Hospital
Recruitment hospital [3] 38
Frankston Private Hospital
Recruitment hospital [4] 39
Southern Oncology Clinical Research Unit
Recruitment postcode(s) [1] 19
3144
Recruitment postcode(s) [2] 20
2109
Recruitment postcode(s) [3] 42
3199
Recruitment postcode(s) [4] 43
5042
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
RemeGen Australia Pty Ltd
Primary sponsor address
Level 5 63 Pirie Street Adelaide SA 5000
Primary sponsor country
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 24
Alfred Health
Address [1] 24
55 Commercial Rd, Melbourne VIC 3004
Country [1] 24
Australia
Date submitted for ethics approval [1] 24
02/06/2021
Approval date [1] 24
04/08/2021
Ethics approval number [1] 24
Ethics committee name [2] 28
Macquarie Univerisity
Address [2] 28
17 Wally's Walk Macquarie University NSW 2109 Australia
Country [2] 28
Australia
Date submitted for ethics approval [2] 28
14/06/2021
Approval date [2] 28
29/07/2021
Ethics approval number [2] 28
Ethics committee name [3] 37
Bellberry Limited
Address [3] 37
123 Glen Osmond Road Eastwood SA 5063
Country [3] 37
Australia
Date submitted for ethics approval [3] 37
30/06/2021
Approval date [3] 37
01/10/2021
Ethics approval number [3] 37
 
Public notes

Contacts
Principal investigator
Title 229 0
Prof
Name 229 0
Gary Richardson
Address 229 0
Cabrini Health 181-183 Wattletree Rd, Malvern VIC 3144
Country 229 0
Australia
Phone 229 0
0395083504
Fax 229 0
Email 229 0
gary.richardson@ocv.net.au
Contact person for public queries
Title 230 0
Dr
Name 230 0
Vincent Zhou
Address 230 0
1445 Research Boulevard, Suite 301 Rockville MD 20850
Country 230 0
United States of America
Phone 230 0
Fax 230 0
Email 230 0
vincent.zhou@remegenbio.com
Contact person for scientific queries
Title 231 0
Dr
Name 231 0
Vincent Zhou
Address 231 0
1445 Research Boulevard, Suite 301 Rockville MD 20850
Country 231 0
United States of America
Phone 231 0
Fax 231 0
Email 231 0
vincent.zhou@remegenbio.com