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

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Brief Title

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

Official Title

An Open-label, Single-arm, Multi-center, Phase II Study of RC48-ADC in Subjects With HER2 Overexpressed Locally Advanced or Metastatic Biliary Tract Cancer (BTC) Who Have Failed First-line Chemotherapy

Brief 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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Objective Response Rate (ORR)

Secondary Outcome

 Duration of Objective Response (DOR)

Condition

Biliary Tract Cancer

Intervention

RC48-ADC

Study Arms / Comparison Groups

 RC48-ADC
Description:  Participants will be treated with RC48-ADC 2.5 mg/kg, once every 2 weeks (Q2W) until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

57

Start Date

August 24, 2020

Completion Date

December 31, 2023

Primary Completion Date

August 1, 2023

Eligibility Criteria

        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≥
        3.0×10^9/L; Neutrophil count ≥ 1.5×10^9/L; Platelets ≥ 80×10^9/L.

        Total bilirubin ≤ 1.5× ULN; AST and ALT ≤ 2.5×ULN or ≤ 5 x ULN with hepatic metastasis;
        Serum creatinine ≤1.5×ULN, 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 086-13910166369, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04329429

Organization ID

RC48-C010


Responsible Party

Sponsor

Study Sponsor

RemeGen Co., Ltd.


Study Sponsor

, , 


Verification Date

September 2021