Actively Recruiting
Phase IB/II Study of Injectable SHR-A1811 with Pyrotinib or SHR-1316 in Advanced Non-small Cell Lung Cancer With HER2
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-04-20
324
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of the injectable drug SHR-A1811 in combination with other antitumor therapies for adults with advanced non-small cell lung cancer that has a HER2 biomarker. This open, multicenter Phase IB/II clinical trial includes a dose-increasing design to study the treatment combinations and their effects on this serious condition. The trial has two parts: Part A tests SHR-A1811 combined with the oral drug Pyrotinib, and Part B tests SHR-A1811 combined with the intravenous drug SHR-1316. SHR-A1811 is given intravenously in both parts. The study explores different dose levels to find suitable combinations and observe their impact. Participants will be monitored closely throughout the study, with assessments including tumor response, adverse events, and antibody levels related to SHR-A1811 and the combined drugs. The main outcomes measured are dose-limiting toxicities, serious adverse events, and objective response rate, with follow-up extending up to two years after the last participant enrolls. Various laboratory tests and blood samples will be collected to track the drug's behavior and immune responses during the study.
CONDITIONS
Brief Title
A Trial of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give informed consent and willing to comply with study requirements
- Age between 18 and 75 years, any gender
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- Diagnosis of advanced or metastatic non-small cell lung cancer
- Provide tumor tissue samples for analysis
- Have failed or be intolerant to prior standard treatments
- At least one measurable tumor lesion
- Adequate vital organ and heart function
- Agree to use birth control during the study
You will not qualify if you...
- Untreated or active brain or central nervous system tumor metastases
- Recent pleural, ascites, or pericardial effusion needing intervention within 7 days
- Systemic antitumor therapy within 4 weeks before study start
- Prior treatment with antibody-conjugated drugs
- Chest radiation over 30 Gy within 6 months before study
- Palliative radiation within 7 days before study
- Unresolved toxicity or complications from previous treatments
- Recent use of certain CYP3A4 affecting drugs
- Systemic immunosuppressants within 14 days before study
- Known or suspected interstitial pneumonia
- Recent gastrointestinal conditions affecting drug absorption
- Active autoimmune diseases
- Poorly controlled or severe heart disease
- Other current or past cancers
- Severe infection within 28 days before study
- Active hepatitis B or tuberculosis within 1 year
- History of immunodeficiency
- Recent live vaccine within 28 days before or during study
- Participation in another clinical trial within 4 weeks or 5 half-lives of prior study drug
- Major surgery within 28 days before study
- Allergy to study drugs or components
- History of severe allergic reactions to similar drugs
- Pregnancy, breastfeeding, or planning pregnancy during study
- Uncontrolled mental illness or substance abuse
- Any condition that increases risk or affects study results as determined by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive injectable SHR-A1811 combined with either Pyrotinib or SHR-1316 as part of their treatment for advanced non-small cell lung cancer.
Visits every 21 days for drug administration and assessments
Duration - Up to 2 years after the last subject is enrolled
Participants are monitored for adverse events, antibody responses, and disease status for up to two years after treatment ends.
Periodic visits over two years for safety and efficacy assessments
Trial Site Locations
Total: 2 locations
1
Shanghai Chest hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
2
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
Research Team
S
Suqiang Yu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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