- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05745740
A Study of RC48-ADC Combined With Pyrotinib For Treatment of Local Advanced or Metastasis NSCLC With HER2 Mutation
November 24, 2023 updated by: RemeGen Co., Ltd.
An Open-label, Single-center, Phase Ib/II Study to Evaluate the Safety, Efficacy and Pharmacokinetics of RC48-ADC Combined With Pyrotinib in Local Advanced or Metastasis NSCLC With HER2 Mutation
This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection combined with pyrotinib in subjects with local advanced or metastatic non-small cell lung cancer with HER2 mutation.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
26
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Na Su
- Phone Number: +8610-58075763
- Email: na.su@remegen.cn
Study Contact Backup
- Name: Jianmin Fang, Ph.D
- Phone Number: +8610-58075763
- Email: Jianminfang@hotmail.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200433
- Shanghai Pulmonary Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Voluntary agreement to provide written informed consent.
- Predicted survival ≥ 12 weeks.
- According to UICC/AJCC 8th Edition, histologically and/or cytologically-confirmed, cannot be surgically removed, locally advanced or metastatic NSCLC.
- Is willing and able to provide an adequate archival tumor tissue sample
- Has relapsed from or is refractory to standard treatment and had received both platinum-based therapy and immunotherapy.
- Measurable lesion according to RECIST 1.1.
- Documented HER2 exon 20 insertion mutation.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- Adequate organ function.
- 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 Criteria:
- No known EGFR, ALK, ROS1, RET, NTRK, MET 14 or BRAF V600E mutation.
- Patient has had previous treatment with HER2-targeted therapy prior to study participation.
- History of major surgery within 4 weeks of planned start of trial treatment.
- Diagnosed with HBsAg, HBcAb positive and HBV DNA copy positive, or HCVAb positive, or HIVAb positive.
- Has received a live virus vaccine within 4 weeks of planned start of trial treatment.
- NYHA Class III heart failure.
- Suffering from active infection requiring systemic treatment.
- Uncontrolled hypertension, diabetes, Interstitial lung Disease, or COPD.
- Treated with systemic treatment (e.g. immunomodulators, corticosteroids or immunosuppressants) for the autoimmune disease within 2 years prior to the study treatment.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RC48-ADC + Pyrotinib
|
RC48-ADC 1.5/2.0
mg/kg by intravenous (IV) infusion, given on Day 1 of each 14-day cycle
Other Names:
Pyrotinib 400 mg by oral once a day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maximal tolerance dose (MTD) of RC48-ADC combined with Pyrotinib
Time Frame: DLT will be evaluated on 28 days of observation period
|
Maximum-tolerated dose (MTD) was defined as the highest dose level at which no more than one of six patients experienced DLT during the DLT assessment window.
|
DLT will be evaluated on 28 days of observation period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Disease control rate (DCR)
Time Frame: Up to approximately 3 years
|
Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.
|
Up to approximately 3 years
|
Overall response rate (ORR)
Time Frame: Up to approximately 3 years
|
The objective response rate will be mainly analyzed by investigators according to the RECIST 1.1 standard tumor evaluation.
|
Up to approximately 3 years
|
Duration of relief (DOR)
Time Frame: Up to approximately 3 years
|
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death.
|
Up to approximately 3 years
|
Progression-free survival (PFS)
Time Frame: Up to approximately 3 years
|
Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death.
|
Up to approximately 3 years
|
Overall survival (OS)
Time Frame: Up to approximately 3 years
|
The objective response rate will be mainly analyzed by investigators according to the RECIST 1.1 standard tumor evaluation
|
Up to approximately 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2024
Primary Completion (Estimated)
December 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
February 16, 2023
First Submitted That Met QC Criteria
February 16, 2023
First Posted (Actual)
February 27, 2023
Study Record Updates
Last Update Posted (Actual)
November 27, 2023
Last Update Submitted That Met QC Criteria
November 24, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC48-C021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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