Advanced Solid Tumors
Conditions
Brief summary
This study is an open-label, multicenter Phase IB/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-A2009 for injection in combination with other antitumor therapies in patients with advanced solid tumors.
Interventions
DRUGSHR-A2009 for injection ； Almonertinib Mesilate Tablets
Phase IB: SHR-A2009 will be administered intravenously，Almonertinib Mesilate Tablets will be administered orally. 2 or 3 dose levels are preset in phase IB. Phase II: 2 dose cohorts will be selected and it's randomization.
DRUGSHR-A2009 for injection；Adebrelimab Injection
Phase IB: SHR-A2009 and Adebrelimab will be administered intravenously. 2 dose levels are preset in phase IB. Phase II: RPD2 will be selected to evaluate preliminary efficacy.
Sponsors
Suzhou Suncadia Biopharmaceuticals 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. Age 18 to 75 years old (inclusive), Female or male 2. Subjects with unresectable locally advanced or metastatic non-small cell lung cancer confirmed by histology or cytology 3. Previously treated by EGFR-TKI or other standard treatment or have not been treated for metastatic setting; 4. At least one measurable tumor lesion according to RECIST v1.1 (enrollment of subjects with only non-target lesions is permitted in Stage IB phase) 5. ECOG performance score of 0-1; 6. Expected survival time ≥ 12 weeks; 7. Adequate bone marrow and organ function 8. Subjects are required to give informed consent for this study prior to the trial and voluntarily sign a written informed consent form.
Exclusion criteria
1. Subjects with active central nervous system (CNS) metastases. 2. Spinal cord compression not cured by surgery and/or radiotherapy cannot be enrolled. 3. Subjects with uncontrolled tumor-related pain 4. Clinically uncontrollable third space fluid 5. Received antitumor therapy such as chemotherapy within 4 weeks prior to the first dose of study drug; 6. Received \>30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug; 7. Major organ surgery or significant trauma within 4 weeks prior to first use of study drug; 8. Concomitant other malignancies ≤ 5 years prior to first dose of study drug; 9. Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis; or other moderate-to-severe lung disease that severely affects lung function 10. Serious cardiovascular disease 11. Presence of refractory nausea, vomiting, chronic gastrointestinal disease, etc.; subjects with active, known or suspected autoimmune diseases 12. Presence of severe infection within 4 weeks prior to first dose of study drug 13. Subjects with clinically significant bleeding symptoms within 3 months prior to the first dose of study drug 14. Arterial/venous thrombotic events within 3 months prior to the first study dose 15. History of immunodeficiency, including a positive HIV test 16. Presence of active hepatitis B or C; 17. History of severe allergic reactions to other monoclonal antibodies or allergic reactions to any component of the SHR-A2009 product. 18. Known history of alcohol or drug dependence or addiction; 19. Persons with mental disorders or poor compliance;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose-limiting toxicity (DLT) (phase IB) | 21 days after the first dose was administered to each subject. |
| Objective Response Rate (ORR) (phase II). | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| PK parameter: toxin-binding antibody of SHR-A2009 | through study completion, an average of 2 years |
| PK parameter: total antibody of SHR-A2009 | through study completion, an average of 2 years |
| PK parameter: free toxin of SHR-A2009 | through study completion, an average of 2 years |
| Plasma concentration of Adebrelimab | through study completion, an average of 2 years |
| Immunogenicity of SHR-A2009 and Adebrelimab (Anti-SHR-A2009 antibody, anti- Adebrelimab antibody ) (Phase IB) | through study completion, an average of 2 years |
| Duration of response(DoR ) | One year after the last subject was enrolled in the group |
| Progression Free Survival(PFS) | 2 years after the last subject was enrolled in the group |
| Objective response rate | 2 years after the last subject was enrolled in the group |
| overall survival (OS) (phase IB) | 3 years after the last subject was enrolled in the group |
| Incidence of AEs（Phase II (efficacy expansion phase)） | from Day1 to 90 days after last dose |
| Incidence of SAEs（Phase II (efficacy expansion phase)） | from Day1 to 90 days after last dose |
Contacts
Primary ContactFei Qiu
Outcome results
None listed