Advanced Solid Tumors
Conditions
Brief summary
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
Carboplatin for injection.
DRUGPaclitaxel injection
Paclitaxel injection.
SHR-1316 injection.
DRUGSHR-9839 for Injection (sc)
SHR-9839 for Injection (sc).
DRUGSHR-9839 for Injection
SHR-9839 for injection.
DRUGSHR-A1921 for Injection
SHR-A1921 for injection.
DRUGSHR-A2009 for Injection
SHR-A2009 for injection.
DRUGAlmonertinib Mesilate Tablets
Almonertinib Mesilate Tablets.
Pemetrexed Disodium for Injection.
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-75 years old (inclusive), regardless of gender. 2. Part A: Patients with locally advanced or metastatic solid tumors confirmed by histology or cytology; Part B: Squamous non-small cell lung cancer. 3. At least one measurable tumor lesion according to RECIST v1.1. 4. ECOG performance score of 0-1. 5. Life expectancy ≥ 12 weeks. 6. Adequate bone marrow and organ function. 7. 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
1. Patients with active central nervous system ( CNS ) metastases. 2. Spinal cord compression not be cured by surgery or radiotherapy. 3. Subjects with uncontrollable tumor-related pain. 4. Moderate and severe ascites with clinical symptoms; Uncontrollable or moderate and above pleural effusion, pericardial effusion. 5. Anti-tumor treatments such as chemotherapy within 4 weeks prior to the first dose of study drug. 6. Received \> 30 Gy chest radiotherapy within 24 weeks prior to the first dose of study drug. 7. Major organ surgery or significant trauma within 4 weeks prior to the first dose of study drug. 8. Concomitant other malignancies ≤ 3 years prior to the first dose of study drug. 9. 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. 10. Serious cardiovascular and cerebrovascular diseases. 11. Patients with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug. 12. History of immunodeficiency, including HIV test positive. 13. Active hepatitis B or hepatitis C infection. 14. History of severe allergic reactions to any component of any study drug to be accepted. 15. Known history of alcohol or drug dependence. 16. Mental disorders or poor compliance. 17. Pregnant or lactating women. 18. Patients with any active, known or suspected autoimmune disease. 19. 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. 20. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of dose-limiting toxicity (DLT) (phase IB) | 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) | Begin from sign the ICF until the end of the safety follow-up period, up to approximately 24 months. | Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0). |
| Objective Response Rate (ORR) (phase II). | The first treatment lasted until disease progression, up to approximately 24 months. | Evaluated using RECIST 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events (AE) and serious adverse events (SAE) and laboratory abnormalities (phase II) | Begin from sign the ICF until the end of the safety follow-up period, up to approximately 24 months. | Assess safety and tolerability of SHR-A2009 by way of adverse events (CTCAE v5.0). |
Countries
China
Contacts
CONTACTQingkai Zhou
Outcome results
None listed