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Trial Title:
A Phase IB/II Clinical Study of SHR-9839 for Injection Combined With Other Anti-tumor Therapies in Patients With Advanced Solid Tumors
NCT ID:
NCT06474455
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Carboplatin
Pemetrexed
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-9839 ；SHR-A2009
Description:
SHR-9839 combined with SHR-A2009
Arm group label:
SHR-9839 combined with SHR-A2009
Intervention type:
Drug
Intervention name:
SHR-9839 ； SHR-A1921
Description:
SHR-9839 combined with SHR-A1921
Arm group label:
SHR-9839 combined with SHR-A1921
Intervention type:
Drug
Intervention name:
SHR-9839 ； pemetrexed ；carboplatin
Description:
SHR-9839 combined with pemetrexed + carboplatin
Arm group label:
SHR-9839 combined with pemetrexed + carboplatin
Intervention type:
Drug
Intervention name:
SHR-9839 ； Almonertinib
Description:
SHR-9839 combined with Almonertinib
Arm group label:
SHR-9839 combined with Almonertinib
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged 18-75 years old (inclusive), regardless of gender.
2. Patients with locally advanced or metastatic solid tumors confirmed by histology or
cytology,.
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. Clinically uncontrollable the third space effusion.
5. Anti-tumor treatments such as chemotherapy within 4 weeks prior to the first dose of
study drug.
6. Received > 30Gy 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Zhejiang
Zip:
310005
Country:
China
Investigator:
Last name:
Zhengbo Song
Email:
Principal Investigator
Facility:
Name:
HeNan CANCER HOSPITAL
Address:
City:
Zhenzhou
Zip:
450003
Country:
China
Investigator:
Last name:
QiMing Wang
Email:
Principal Investigator
Start date:
June 2024
Completion date:
June 2027
Lead sponsor:
Agency:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06474455
