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

NCT05628857 | Completed Phase 2

• 1 other identifier: RC108-C002
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Digestive Cancer

Keywords

Digestive Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

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

  Up to 24 Months

Secondary Outcomes (10)

• DCR

  Up to 24 Months

• Adverse Events

  Up to 24 Months

• DOR

  Up to 24 Months

• TTP

  Up to 24 Months

• PFS

  Up to 24 Months

Study Arms (4)

Cohort 1

EXPERIMENTAL

gastric cancer patients

Drug: RC108

cohort 2

EXPERIMENTAL

colorectal cancer patients

Drug: RC108

cohort 3

EXPERIMENTAL

liver cancer patients

Drug: RC108

cohort 4

EXPERIMENTAL

other digestive system malignancies, including esophageal cancer, pancreatic cancer, gallbladder cancer, etc.

Drug: RC108

Interventions

RC108 DRUG

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

Cohort 1; cohort 2; cohort 3; cohort 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Beijing Cancer Hopspital

Beijing, Beijing Municipality, 000000, China

Location

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Officials

• Jianmin Fang, Ph.D

  RemeGen Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 29, 2022
• Study Start: November 11, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 6, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)