A Study of RC48-ADC in Subjects With HER2 Overexpressed Metastatic Biliary Tract Cancer

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    57
  • sponsor
    RemeGen Co., Ltd.
Updated on 3 March 2022
measurable disease
fluorouracil
metastasis
neutrophil count
liver metastasis
gemcitabine
HER2
cholangiocarcinoma
metastatic biliary tract carcinoma
gallbladder cancer
biliary tract cancer

Summary

This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with locally advanced or metastatic HER2 overexpressed biliary tract cancer who have failed first-line chemotherapy.

Details
Condition Biliary Tract Cancer
Treatment RC48-ADC
Clinical Study IdentifierNCT04329429
SponsorRemeGen Co., Ltd.
Last Modified on3 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Voluntary agreement to provide written informed consent
Male or female, Age 18 years
Predicted survival 12 weeks
Diagnosed with histologically or cytologically-confirmed locally advanced or metastatic biliary tract cancer, including extra- or intra-hepatic bile duct cancer, gallbladder cancer, and ampulla cancer
Patients who have previously failed first-line chemotherapy. First-line chemotherapy failure is defined as disease progression (with imaging evidence of disease progression) during or within three months after treatment based on a two-drug combination of gemcitabine, platinum, or fluorouracil, or patients still cannot tolerate drug toxicity after two standardized drug reductions, or the disease progresses or relapses during neoadjuvant / adjuvant therapy or within six months after the end of treatment
At least one measurable lesion according to RECIST 1.1. The measurable lesion has not been treated with local treatment, including local radiotherapy, ablation and interventional treatment
HER2 overexpression (i.e. IHC 2+or 3+) as confirmed by the central laboratory. Subject is able to provide specimens from primary or metastatic lesions for HER2 tests
Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
Adequate organ function, evidenced by the following laboratory results
Left ventricular ejection fraction 50 %. Hemoglobin (HGB) 90 g/L; WBC count
010^9/L; Neutrophil count 1.510^9/L; Platelets 8010^9/L
Total bilirubin 1.5 ULN; AST and ALT 2.5ULN or 5 x ULN with hepatic
metastasis; Serum creatinine 1.5ULN, or 50 ml/min of creatinine clearance
(CrCl) according to Cockcroft-Gault formula
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 at least one form of highly effective contraception. Female subjects must have serum pregnancy test negative within 7 days before study enrollment and must be non-lactating. Male subjects and their female partner who are of child-bearing potential must agree to use at least one form of highly effective contraception
Willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol

Exclusion Criteria

Received chemotherapy (treated with nitrosourea and mitomycin C within 6 weeks, oral fluorouracil within 2 weeks), radiotherapy (palliative local radiotherapy for bone metastases within 2 weeks before dosing), targeted therapy (the elution period of small molecule targeted drug is 2 weeks or 5 half-lives, whichever is longer), immunotherapy, or Chinese traditional medicine therapy (used Chinese traditional medicine with anti-tumor indications within one week) within 4 weeks before enrollment
Patients with biliary obstruction were excluded, unless the biliary obstruction was locally treated, such as endoscopic stent implantation, percutaneous liver puncture drainage, etc., with total bilirubin is reduced to 1.5 times of ULN
Have a history of malignancies other than biliary malignancies (except cured cervical carcinoma in situ or basal cell carcinoma of the skin and other malignancies that have been cured for 5 years)
Previously received the treatment of other antibody-drug conjugates, e.g. T-DM1 and SGN-35
Have central nervous system (CNS) metastases and / or cancerous meningitis. Subjects who have received brain metastasis treatment may consider participating in this study, provided that the condition is stable for at least 6 months, and no disease progression has been confirmed by imaging examination within 4 weeks before administration, and all neurological symptoms have returned to baseline Level, no evidence of new or enlarged brain metastases, and discontinuation of radiation, surgery, or steroid treatment at least 28 days before the first dose of study treatment. This exception does not include cancerous meningitis, which should be ruled out regardless of its clinical status
Have severe, uncontrollable companion diseases, including combined uncontrollable infections, active tuberculosis, uncontrollable diabetes, and cardiovascular disease (New York Heart Association classification of Grade III or Grade IV heart failure, above Grade II cardiac conduction blockage, myocardial infarction, unstable arrhythmia or unstable angina in the past 12 months, cerebral infarction within 6 months, etc.), lung disease (History of interstitial pneumonia, obstructive pulmonary disease, and symptomatic bronchi spasm), deep vein thrombosis or pulmonary embolism within 12 months, decompensated liver cirrhosis
Have active autoimmune diseases that require systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressive drugs) in the past 2 years, the related alternative treatments (such as thyroxine, insulin, or adrenal or pituitary insufficiency corticosteroid replacement therapy) are permitted
Toxicity of previous anti-tumor treatment not recovered to CTCAE Grade 0-1 (with exception of Grade 2 alopecia), except for those who have hair loss, pigmentation, anemia, weakness and those who cannot recover from the long-term toxicity caused by radiotherapy
HIV positive; HBsAg positive with HBV-DNA positive (2000 copies/ml); HCV positive, except for patients with HCV positive and HCV-RNA negative in PCR test
History of major surgery within 4 weeks of planned start of trial treatment, or patients with previous allogeneic hematopoietic stem cell transplant or organ transplant
Has received anti-cancer vaccine within 4 weeks of planned start of trial treatment, or planned to receive anti-cancer vaccine during trial treatment
Pleural or abdominal effusion with clinical symptoms that requires ongoing treatment
Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
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