Recruiting NCT06474455
A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-9839 for Injection, SHR-A1921 for Injection, SHR-A2009 for Injection, Almonertinib Mesilate Tablets.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase IB/II, Open-Label, Multicentre Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-9839 for Injection in Combination With Other Therapies in Patients With Advanced Solid Tumors
Overview
This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability and efficacy of SHR-9839 for injection in combination with other antitumor therapies in patients with advanced solid tumors.
Interventions
- Drug SHR-9839 for Injection
SHR-9839 for injection. - Drug SHR-A1921 for Injection
SHR-A1921 for injection. - Drug SHR-A2009 for Injection
SHR-A2009 for injection. - Drug Almonertinib Mesilate Tablets
Almonertinib Mesilate Tablets. - Drug Pemetrexed Disodium for Injection
Pemetrexed Disodium for Injection. - Drug Carboplatin for injection
Carboplatin for injection. - Drug Paclitaxel injection
Paclitaxel injection. - Drug SHR-1316 Injection
SHR-1316 injection. - Drug SHR-9839 for Injection (sc)
SHR-9839 for Injection (sc).
Primary outcome measures
- Incidence of dose-limiting toxicity (DLT) (phase IB) [Time frame: 21 days after the first dose was administered to each subject, up to approximately 24 months.]
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) and laboratory abnormalities (phase IB) [Time frame: Begin from sign the ICF until the end of the safety follow-up period, up to approximately 24 months.]
- Objective Response Rate (ORR) (phase II). [Time frame: The first treatment lasted until disease progression, up to approximately 24 months.]
Secondary outcome measures (1)
- Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory abnormalities (phase II) [Time frame: Begin from sign the ICF until the end of the safety follow-up period, up to approximately 24 months.]
Eligibility criteria
Inclusion criteria
- Aged 18-75 years old (inclusive), regardless of gender.
- Part A: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology; Part B: Squamous non-small cell lung cancer.
- At least one measurable tumor lesion according to RECIST v1.1.
- ECOG performance score of 0-1.
- Life expectancy ≥ 12 weeks.
- Adequate bone marrow and organ function.
- Have the ability to informed consent, have signed the IRB / EC approved informed consent and dated, willing and able to comply with the treatment plan to visit the inspection and other procedural requirements.
Exclusion criteria
- Patients with active central nervous system ( CNS ) metastases.
- Spinal cord compression not be cured by surgery or radiotherapy.
- Subjects with uncontrollable tumor-related pain.
- Moderate and severe ascites with clinical symptoms; Uncontrollable or moderate and above pleural effusion, pericardial effusion.
- Anti-tumor treatments such as chemotherapy within 4 weeks prior to the first dose of study drug.
- Received > 30 Gy chest radiotherapy within 24 weeks prior to the first dose of study drug.
- Major organ surgery or significant trauma within 4 weeks prior to the first dose of study drug.
- Concomitant other malignancies ≤ 3 years prior to the first dose of study drug.
- History of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis or inability to exclude interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function.
- Serious cardiovascular and cerebrovascular diseases.
- Patients with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug.
- History of immunodeficiency, including HIV test positive.
- Active hepatitis B or hepatitis C infection.
- History of severe allergic reactions to any component of any study drug to be accepted.
- Known history of alcohol or drug dependence.
- Mental disorders or poor compliance.
- Pregnant or lactating women.
- Patients with any active, known or suspected autoimmune disease.
- Patients received systemic immunostimulatory therapy within 4 weeks before starting the study, or received systemic immunosuppressive therapy within 2 weeks before starting the first study.
- Patients who had previously used immune checkpoint inhibitors were not allowed to be enrolled in this study if they had a CTCAE grade 3 immune-related adverse event that lasted for 4 weeks or more, or a CTCAE grade 4 immune-related adverse event.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Henan Cancer Hospital — Zhengzhou
- Zhejiang Cancer Hospital — Hangzhou
Identifiers
NCT: NCT06474455 · SHR-9839-201