A Study of RC108-ADC in Subjects With Advanced Digestive System Malignant Tumor

January 4, 2026 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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 000000
        • Beijing Cancer Hopspital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntary agreement to provide written informed consent.
  2. Male or female, aged between 18 to 75 years.
  3. Predicted survival for ≥ 12 weeks. Diagnosed with histologically or cytologically confirmed locally advanced or metastatic Digestive System Malignant Tumor.
  4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  5. 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.

  6. 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.

  7. bone marrow function: Hemoglobin ≥ 9g/dL; Absolute neutrophil count ≥ 1.5×10^9 /L Platelets ≥ 100×10^9 /L.
  8. hepatic function: Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN and ≤ 5 x ULN with hepatic metastasis
  9. renal, and hepatic function: Serum creatinine ≤1.5×ULN.
  10. Cardiac ejection fraction ≥ 50%. Median QTc < 450 ms.
  11. c-Met positive as confirmed by the central laboratory.
  12. Measurable lesion according to RECIST 1.1.

Exclusion Criteria:

  1. Known hypersensitivity to the components of RC108-ADC.
  2. Toxicity of previous anti-tumor treatment not recovered to CTCAE (v5.0) Grade 0-1 (with exception of Grade 2 alopecia).
  3. Uncontrolled pericardial effusion or cardiac tamponade, or pleural or abdominal effusion with clinical symptoms.
  4. History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment.
  5. History of major surgery within 4 weeks of planned start of trial treatment.
  6. Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
  7. Currently known active infection with HIV or tuberculosis.
  8. Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive.
  9. 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.
  10. 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.
  11. Known central nervous system metastases.
  12. Uncontrolled hypertension, diabetes, pulmonary fibrosis, acute lung disease, Interstitial lung disease, or liver cirrhosis;
  13. Pregnancy or lactation.
  14. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1
gastric cancer patients
Drug: RC108
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
Drug: RC108
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
Drug: RC108
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.
Drug: RC108
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RemeGen Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

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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