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COMPLETEDPHASE1/PHASE2

A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer

A Phase Ib Study to 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

NCT04311034•RemeGen Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntary signed informed consent.
•2. Male or female, Aged between 18 to 75 years.
•3. Predicted survival ≥ 12 weeks.
•4. According to UICC/AJCC 8th Edition, histologically and/or cytologically-confirmed, cannot be surgically removed, locally advanced or metastatic NSCLC.
•5. Locally advanced or metastatic disease had failed at least one systemic treatment.
•6. Based on imaging judgment (RECIST 1.1) or clinical status, tumor progression during or after the last treatment before enrollment.
•7. 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.
•8. 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+.
•9. Measurable lesion according to the RECIST 1.1.
•10. ECOG performance status score of 0 or 1.
+3 more criteria

Exclusion Criteria

•1. Have used T-DM1 or participated in other HER2-ADC clinical studies.
•2. 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.
•3. Major surgery was performed within 4 weeks prior to study administration and did not fully recover.
•4. Other clinical trial drugs have been used within 4 weeks before the start of study administration.
•5. Live vaccine received within 4 weeks before the start of study administration.
•6. Have received anti-tumor Chinese medicine treatment within 2 weeks before the start of study administration.
•7. 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) .
•8. 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.
•9. 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).
•10. Diagnosed with HBsAg positive and HBV DNA positive, or HCV Ab positive, or HIV Ab positive.
+12 more criteria

Locations (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

September 26, 2018

Primary Completion Date

December 21, 2021

Completion Date

May 30, 2022

Last Updated

December 18, 2023

Enrollment

ACTUAL participants

Conditions

Non Small Cell Lung Cancer

Interventions

RC48

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer

Inclusion Criteria

Exclusion Criteria

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