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Unresectable Solid TumorPhase 1NCT04914117

A Study of RC118 in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours

A Phase 1 study testing RC118 for injection in people with Unresectable Solid Tumor and Metastatic Solid Tumor, run by RemeGen Co., Ltd. at 4 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
RC118 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
4 sitesAustralia
Study dates
29 Nov 2021to 11 Mar 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be able to provide documented voluntary informed consent.
  • Male or female patient ≥ 18 years and ≤ 75 years.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) score 0 or 1.
  • The expected survival period exceeds 12 weeks.
  • At least one target lesion that can be measured per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
  • Histologically documented, incurable, unresectable locally advanced or metastatic tumours that are intolerable or refractory to standard therapies.
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  • 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.
  • 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.
  • 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.

Who cannot join

  • Women who are pregnant or breastfeeding.
  • 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.
  • Received vaccines within 4 weeks prior to administration or plan on receiving any vaccine during the study.
  • Subjects with a history of other acquired/congenital immunodeficiency diseases or organ transplantation.
  • 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.
  • Allergic constitution or allergic to known research drug active ingredients or excipient.
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  • 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.
  • 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.
  • 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.
  • 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.
  • A clinically significant active infection judged by the investigator.
  • 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.
  • 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.
  • 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.
  • Patients with known current alcohol dependence or drug abuse.
  • Patients with a long-term history of systemic steroid therapy. Patients with short-term (≤ 7 days) use and drug withdrawal > 2 weeks are eligible.
  • 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.
  • History or presence of Grade ≥ 2 peripheral neuropathy.
  • 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.
  • 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.
  • Patients who are not appropriate for this clinical trial at the discretion of the investigator.

Trial locations and contacts

4 sites in 1 country.

Australia4 sites

  • Remegen Site #14

    Bedford Park, South Australia, 5042

  • Remegen Site #13

    Frankston, Victoria, 3199

  • Remegen Site #12

    Macquarie Park, New South Wales, 2109

  • Remegen Site #11

    Malvern, Victoria, 3144

Other trials in Australia

About this study

Official title: Phase 1, First-in-Human, Multicentre, Open-label Study of RC118 for Injection in Patients With Locally Advanced Unresectable/Metastatic Solid Tumours

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).

Read the detailed description

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.

Being tested
RC118 for injection
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RC118 for injectionDrug

    RC118 will be administered intravenously (IV) on Day 1 of every 14-day cycle.

Study groups in NCT04914117
Study groupRoleWhat they receive
RC118 for injectionExperimentalPart 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.
Receives: Drug: RC118 for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 18 months

  2. 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.

    Measured: Up to 18 months

  3. Adverse Events

    The adverse events occurring or worsening on or after the first dose of the study drug will be recorded.

    Measured: Up to 18 months

Secondary outcomes (8)

  1. 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.

    Measured: Up to 18 months

  2. 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.

    Measured: Up to 18 months

  3. Disease Control Rate (DCR)

    DCR is the proportion of patients with disease control.

    Measured: Up to 18 months

  4. 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.

    Measured: Up to 18 months

  5. Immunogenicity

    Incidence of anti-drug antibody (ADA) against RC118

    Measured: Up to 18 months

  6. Maximum Plasma Concentration [Cmax]

    Cmax of total antibodies, RC118 and free MMAE

    Measured: Up to 18 months

  7. Area under the plasma concentration [AUC]

    AUC of total antibodies, RC118 and free MMAE

    Measured: Up to 18 months

  8. Tmax

    Peak time (Tmax) of total antibodies, RC118 and free MMAE

    Measured: Up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jun 2021
  2. Study start29 Nov 2021
  3. Primary completion15 Nov 2022
  4. Study completion11 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04914117
Sponsor's protocol ID
RC118G001
Status last verified
Jun 2023
First submitted
21 May 2021
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RC118 for injection in people with Unresectable Solid Tumor and Metastatic Solid Tumor, run by RemeGen Co., Ltd. at 4 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD/MAD based on number of dose-limiting toxicities (DLTs) (time frame: Up to 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04914117.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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