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Digestive CancerPhase 2NCT05628857

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

A Phase 2 study testing RC108 in people with Digestive Cancer, run by RemeGen Co., Ltd. at 1 site in China.

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

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Digestive Cancer
What is being tested?
RC108
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
1 siteChina
Study dates
11 Nov 2022to 31 Dec 2025
Phase
Phase 2
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

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hopspital

    Beijing, Beijing Municipality, 000000

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
RC108
Keywords
Digestive Cancer
Medical subject headings
Gastrointestinal Neoplasms

What participants receive

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

  • RC108Drug

    RC108 is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration.

Study groups in NCT05628857
Study groupRoleWhat they receive
Cohort 1Experimentalgastric cancer patients
Receives: Drug: RC108
cohort 2Experimentalcolorectal cancer patients
Receives: Drug: RC108
cohort 3Experimentalliver cancer patients
Receives: Drug: RC108
cohort 4Experimentalother digestive system malignancies, including esophageal cancer, pancreatic cancer, gallbladder cancer, etc.
Receives: Drug: RC108

What is being measured

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

  1. Objective Response Rate (ORR)

    Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR)

    Measured: Up to 24 Months

Secondary outcomes (10)

  1. DCR

    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)

    Measured: Up to 24 Months

  2. Adverse Events

    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.

    Measured: Up to 24 Months

  3. DOR

    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.

    Measured: Up to 24 Months

  4. TTP

    Time to progression will be measured from the first day of study drug until progression.

    Measured: Up to 24 Months

  5. PFS

    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.

    Measured: Up to 24 Months

  6. OS

    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.

    Measured: Up to 5 years

  7. Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)

    Area under the curve (AUC) from time zero to the last measurable concentration AUC (0-t)

    Measured: Up to 24 Months

  8. Maximum observed plasma concentration (Cmax)

    Maximum observed plasma concentration (Cmax)

    Measured: Up to 24 Months

  9. Time to Cmax (Tmax)

    Time to Cmax (Tmax).

    Measured: Up to 24 Months

  10. Terminal elimination half life

    Terminal elimination half life.

    Measured: Up to 24 Months

Timeline

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

  1. First posted29 Nov 2022
  2. Study start11 Nov 2022
  3. Primary completion31 Dec 2025
  4. Study completion31 Dec 2025

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05628857
Sponsor's protocol ID
RC108-C002
Status last verified
Apr 2025
First submitted
17 Nov 2022
Last updated
6 Jan 2026
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 2 study testing RC108 in people with Digestive Cancer, run by RemeGen Co., Ltd. at 1 site in China.

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 13 inclusion and 14 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 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Objective Response Rate (ORR) (time frame: Up to 24 Months). 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 NCT05628857.

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 6 Jan 2026.

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