- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05628857
A Study of RC108-ADC in Subjects With Advanced Digestive System Malignant Tumor
November 28, 2023 updated by: RemeGen Co., Ltd.
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of RC108 for Injection in the Treatment of Patients With c-Met-positiveAdvanced Digestive System Malignant Tumor
A multi-center, open-label, study designed to evaluate the preliminary efficacy, safety and pharmacokinetics of RC108 in patients with c-Me-positive advanced digestive system malignancies.
Study Overview
Detailed Description
The primary purpose of this trial is to evaluate the preliminary efficacy, safety and efficacy of RC108 in patients with c-Me positive advanced gastrointestinal malignancies such as gastric, colorectal, esophageal, hepatic, pancreatic and bile duct cancers.
Study Type
Interventional
Enrollment (Estimated)
240
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jianmin Fang, Ph.D
- Phone Number: +8610-58075763
- Email: Jianminfang@hotmail.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 000000
- Recruiting
- Beijing Cancer Hopspital
-
Contact:
- lin shen, PHD
- Phone Number: 13911219611
- Email: linshenpku@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Voluntary agreement to provide written informed consent.
- Male or female, aged between 18 to 75 years.
- Predicted survival for ≥ 12 weeks. Diagnosed with histologically or cytologically confirmed locally advanced or metastatic Digestive System Malignant Tumor.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- All female subjects will be considered to be of child-bearing potential unless they are postmenopausal, or have been sterilized surgically. Female subjects of child-bearing potential must agree to use two forms of highly effective contraception. Male subjects and their female partner who are of child-bearing potential must agree to use two forms of highly effective contraception.
Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
Adequate organ function, evidenced by the following laboratory result Participant has adequate bone marrow, renal, and hepatic function.
- bone marrow function: Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×10^9 /L Platelets ≥ 100×10^9 /L.
- hepatic function: Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN and ≤ 5 x ULN with hepatic metastasis
- renal, and hepatic function: Serum creatinine ≤1.5×ULN.
- Cardiac ejection fraction ≥ 50%. Median QTc < 450 ms.
- c-Met positive as confirmed by the central laboratory.
- Measurable lesion according to RECIST 1.1.
Exclusion Criteria:
- Known hypersensitivity to the components of RC108-ADC.
- Toxicity of previous anti-tumor treatment not recovered to CTCAE (v5.0) Grade 0-1 (with exception of Grade 2 alopecia).
- Uncontrolled pericardial effusion or cardiac tamponade, or pleural or abdominal effusion with clinical symptoms.
- History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.
- History of major surgery within 4 weeks of planned start of trial treatment.
- Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
- Currently known active infection with HIV or tuberculosis.
- Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or cancers with a similar curative outcome as those mentioned above.
- Known central nervous system metastases.
- Uncontrolled hypertension, diabetes, pulmonary fibrosis, acute lung disease, Interstitial lung disease, or liver cirrhosis;
- Pregnancy or lactation.
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort 1
gastric cancer patients
|
RC108 is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration.
|
Experimental: cohort 2
colorectal cancer patients
|
RC108 is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration.
|
Experimental: cohort 3
liver cancer patients
|
RC108 is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration.
|
Experimental: cohort 4
other digestive system malignancies, including esophageal cancer, pancreatic cancer, gallbladder cancer, etc.
|
RC108 is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Response Rate (ORR)
Time Frame: Up to 24 Months
|
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)
|
Up to 24 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DCR
Time Frame: Up to 24 Months
|
The disease control rate is the proportion of those subjects with complete response, partial response, or stable disease, as defined by Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1)
|
Up to 24 Months
|
Adverse Events
Time Frame: Up to 24 Months
|
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
|
Up to 24 Months
|
DOR
Time Frame: Up to 24 Months
|
DOR is defined as the time from the participant's initial objective response to study drug therapy to disease progression or death, whichever occurs first.
|
Up to 24 Months
|
TTP
Time Frame: Up to 24 Months
|
Time to progression will be measured from the first day of study drug until progression.
|
Up to 24 Months
|
PFS
Time Frame: Up to 24 Months
|
PFS time is defined as the time from the participant's first dose of RC108 to either the participant's disease progression or death, whichever occurs first.
|
Up to 24 Months
|
OS
Time Frame: Up to 5 years
|
Duration from date of sub-study registration (or date of screening/pre-screening registration if patient never enrolls in a sub-study) to date of death due to any cause.
|
Up to 5 years
|
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)
Time Frame: Up to 24 Months
|
Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)
|
Up to 24 Months
|
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 24 Months
|
Maximum observed plasma concentration (Cmax)
|
Up to 24 Months
|
Time to Cmax (Tmax)
Time Frame: Up to 24 Months
|
Time to Cmax (Tmax).
|
Up to 24 Months
|
Terminal elimination half life
Time Frame: Up to 24 Months
|
Terminal elimination half life.
|
Up to 24 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jianmin Fang, Ph.D, RemeGen Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 11, 2022
Primary Completion (Estimated)
October 15, 2024
Study Completion (Estimated)
October 15, 2025
Study Registration Dates
First Submitted
November 17, 2022
First Submitted That Met QC Criteria
November 17, 2022
First Posted (Actual)
November 29, 2022
Study Record Updates
Last Update Posted (Actual)
November 30, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC108-C002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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