Injectable SHR-A1811 with Pyrotinib or SHR-1316 for advanced lung cancer

Phase IB/II Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Efficacy of Injectable SHR-A1811 in Combination With Pyrotinib or SHR-1316 in Subjects With Advanced Non-small Cell Lung Cancer With HER2

This study is testing if a new injectable treatment called SHR-A1811, used with either Pyrotinib or SHR-1316, can help people with advanced lung cancer that has a specific marker called HER2.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 324 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Drugs / interventions: pyrrolitinib, radiation, Pyrotinib
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT05482568 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of SHR-A1811 when combined with either Pyrotinib or SHR-1316 in patients with advanced non-small cell lung cancer (NSCLC) that expresses HER2. The trial is structured in two parts: Part A focuses on dose escalation and efficacy exploration of SHR-A1811 with Pyrotinib, while Part B examines the same for SHR-A1811 with SHR-1316. It is an open, multicenter trial designed to assess the potential benefits of these combinations in treating advanced NSCLC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced or metastatic non-small cell lung cancer who have failed or are intolerant to prior standard care.

Not a fit: Patients with untreated or active central nervous system tumor metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced non-small cell lung cancer.

How similar studies have performed: Other studies have shown promise in using targeted therapies for advanced lung cancer, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Ability to give informed consent, signed and dated IRB/EC approved informed consent, willing and able to comply with treatment planning visits, tests and other procedural requirements
2. When signing the informed consent, the age is 18-75 years old (including both ends), and there is no gender limitation
3. The ECOG score is 0 or 1
4. The expected survival is ≥12 weeks
5. Subjects with advanced or metastatic non-small cell lung cancer
6. Formalin fixed, paraffin-embedded tumor tissue blocks or sections of unstained tumor specimens are provided
7. Subjects who have failed prior standard care or are intolerant to standard care
8. There is at least one measurable lesion
9. Vital organs are functioning well
10. Heart function is good
11. Agree to birth control

Exclusion Criteria:

1. There are untreated or active central nervous system (CNS) tumor metastases
2. Pleural, ascites, or pericardial effusion requiring intervention occurred within 7 days prior to initial administration
3. Systemic antitumor therapy was performed 4 weeks prior to study initiation
4. Prior treatment with antibody-conjugated drugs
5. Received \>30 Gy chest radiation within 6 months prior to initial administration
6. Palliative radiotherapy was completed within 7 days prior to initial administration
7. Failure to recover from toxicity and/or complications of previous interventions to nCI-CTCAE ≤1
8. The half-life of CYP3A4 suppressor, moderate inhibitor or strong inducer or moderate inducer is less than 3 or less than 14 days from the date of first drug use, and the shorter is selected
9. Received systemic immunosuppressant therapy within 14 days prior to the first study
10. Subjects with known or suspected interstitial pneumonia
11. In the first study, failure to swallow, chronic diarrhea, gastroenteritis, intestinal obstruction, gastrointestinal perforation, postgastrectomy, or colitis, or other medical conditions or special conditions affecting drug administration and absorption occurred within 28 days prior to administration
12. Presence of any active, known or suspected autoimmune disease
13. Have poorly controlled or severe cardiovascular disease
14. Previous or concurrent malignancy
15. Subjects who developed a severe infection within 28 days prior to the first dose
16. Active hepatitis B
17. There were active tuberculosis patients within 1 year before enrollment
18. There is a history of immunodeficiency
19. Live attenuated vaccine was administered within 28 days prior to initial study administration or is expected to be administered during study treatment
20. Subjects who are participating in another clinical study or who have had their first dose less than 4 weeks since the end of the previous clinical study (last dose) or 5 half-lives of the study drug, whichever is shorter
21. Major surgery other than diagnosis or biopsy was performed within 28 days prior to initial administration
22. People who are known to be allergic to sir-A1811, pyrrolitinib, or any of the components of SIR-1316
23. History of severe allergic reactions to other monoclonal antibody/fusion protein drugs
24. Female subjects who are pregnant, breast-feeding, or planning to become pregnant during the study
25. Uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse and detention
26. Any other conditions that, in the investigator's judgment, may increase the risk of study participation, interfere with study results, or make study participation unsuitable

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Shanghai Chest hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Suqiang Yu

Conditions Advanced Non-small Cell Lung Cancer