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Trial Title:
A Study of RC108-ADC in Subjects With Advanced Digestive System Malignant Tumor
NCT ID:
NCT05628857
Condition:
Digestive Cancer
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Digestive Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
RC108
Description:
RC108 is comprised of an antibody component conjoined to a drug component in a
lyophilized powder, which is made into solution for intravenous administration.
Arm group label:
Cohort 1
Arm group label:
cohort 2
Arm group label:
cohort 3
Arm group label:
cohort 4
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hopspital
Address:
City:
Beijing
Zip:
000000
Country:
China
Status:
Recruiting
Contact:
Last name:
lin shen, PHD
Phone:
13911219611
Email:
linshenpku@163.com
Start date:
November 11, 2022
Completion date:
October 15, 2025
Lead sponsor:
Agency:
RemeGen Co., Ltd.
Agency class:
Industry
Source:
RemeGen Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05628857
