Status:
COMPLETED
A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer
Lead Sponsor:
RemeGen Co., Ltd.
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will evaluate the efficacy and safety of RC48-ADC for injection in subjects with advanced non-small cell lung cancer with HER2 overexpression or HER2 mutation.
Eligibility Criteria
Inclusion
- Voluntary signed informed consent.
- Male or female, Aged between 18 to 75 years.
- Predicted survival ≥ 12 weeks.
- According to UICC/AJCC 8th Edition, histologically and/or cytologically-confirmed, cannot be surgically removed, locally advanced or metastatic NSCLC.
- Locally advanced or metastatic disease had failed at least one systemic treatment.
- Based on imaging judgment (RECIST 1.1) or clinical status, tumor progression during or after the last treatment before enrollment.
- HER2 protein overexpression (IHC 2+ or 3 +) or HER2 gene mutation (defined as exon 20 mutation), the previous test results confirmed by the researchers, both research centers and major research centers can be acceptable.
- The researchers confirmed that the EGFR gene mutation status was negative or positive. For EGFR gene mutation-positive patients, one of the following is met: 1) T790M gene mutation negative, c-Met gene amplification negative and HER2 IHC 2+ or 3+ after first-generation EGFR-TKI drug resistance; 2) Third-generation EGFR-TKI treatment failed and HER2 IHC 2+ or 3+.
- Measurable lesion according to the RECIST 1.1.
- ECOG performance status score of 0 or 1.
- Adequate organ function: LVEF ≥ 50 %. Hemoglobin ≥ 9g/dL; ANC ≥ 1.5×10\^9 /L; Platelets ≥ 100×10\^9 /L; Total bilirubin ≤ 1.5×ULN; ALT, AST and ALP ≤ 2.5×ULN and ≤ 5 x ULN with hepatic metastasis; Serum creatinine ≤1.5×ULN, or CrCl ≥ 60mL/min; INR≤ 1.5× ULN, APTT≤ 1.5× ULN.
- For female subjects: should be surgically sterilized, postmenopausal, or agree to use a medically approved contraceptive (such as an intrauterine device, contraceptives, or condoms) during study treatment and within 6 months after the end of study, the blood pregnancy test within 7 days of study enrollment must be negative and must be non-lactating. Male subjects: Patients who should be surgically sterilized or agree to use a medically approved contraceptive during the study treatment period and within 6 months after the end of the study.
- Willing and able to follow trial and follow-up procedures.
Exclusion
- Have used T-DM1 or participated in other HER2-ADC clinical studies.
- Received anti-tumor treatment 4 weeks before study administration, including chemotherapy (late toxicity chemotherapy was 6 weeks before study administration), radiotherapy (palliative local radiotherapy for bone metastases was 2 weeks before the study administration), biological therapy (small molecule targeted drugs were 8 days before the study administration) or immunotherapy, etc.
- Major surgery was performed within 4 weeks prior to study administration and did not fully recover.
- Other clinical trial drugs have been used within 4 weeks before the start of study administration.
- Live vaccine received within 4 weeks before the start of study administration.
- Have received anti-tumor Chinese medicine treatment within 2 weeks before the start of study administration.
- History of other malignant tumors within 5 years before signing the informed consent (except for non-melanoma skin cancer, cervical carcinoma in situ that has been effectively treated, or malignant tumors that have been resolved for more than 3 years after effective treatment and are considered to be cured) .
- Toxicity of previous anti-tumor treatment has not recovered to CTCAE (version 4.03) 0-1, except for the following conditions: a. Hair loss; b. Pigmentation; c. Long-term toxicity caused by radiotherapy, which cannot be restored by the judgement of the investigator.
- Active central nervous system (CNS) metastasis and/or cancerous meningitis (subjects who have received brain metastasis treatment can participate in this study, provided that the condition is stable (no evidence of progression confirmed by imaging studies at least 4 weeks before study dosing, and all neurological symptoms have returned to baseline levels), no evidence of new or enlarged brain metastases, and discontinuation of steroid treatment at least 7 days before the first dose of trial treatment. This exception does not include cancerous meningitis, which should be excluded whether clinical status was stable).
- Diagnosed with HBsAg positive and HBV DNA positive, or HCV Ab positive, or HIV Ab positive.
- Severe arterial/venous thrombosis or cardio-cerebral vascular accidents occurred within 1 year before the study, such as deep vein thrombosis, pulmonary embolism, cerebral infarction, cerebral hemorrhage, myocardial infarction, etc.
- Active infections requiring systemic treatment.
- Other lung diseases required systemic treatment such as active tuberculosis, interstitial lung disease, etc.
- Uncontrolled systemic diseases such as diabetes, hypertension, cirrhosis, etc.
- Heart failure graded 3 or above by the NYHA.
- Pleural effusion, pericardial effusion, or peritoneal effusion with clinical symptoms that cannot be controlled by drainage or other methods.
- Mental illness or substance abuse known to have an impact on compliance with study requirements.
- Hypersensitivity or delayed allergic reaction to certain components of RC48-ADC or similar drugs.
- Any other disease, metabolic abnormality, abnormal physical examination or abnormal laboratory test, etc., based on the judgment of the investigator, it is reasonable to suspect that the patient has a certain disease or condition unsuitable for the research drug, or will affect the interpretation of the research results, or putting patients at high risk.
- Pregnant or lactating female or female / male who are planning to have children.
- Insufficient adherence to participate in this clinical study.
- Any other condition in which the investigator considers the patient unsuitable for this study.
Key Trial Info
Start Date :
September 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04311034
Start Date
September 26 2018
End Date
May 30 2022
Last Update
December 18 2023
Active Locations (1)
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1
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China, 200433