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
Last Updated: 2024-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1/PHASE2
156 participants
INTERVENTIONAL
2024-06-30
2027-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SHR-9839 combined with SHR-A2009
SHR-9839 ；SHR-A2009
SHR-9839 combined with SHR-A2009
SHR-9839 combined with SHR-A1921
SHR-9839 ； SHR-A1921
SHR-9839 combined with SHR-A1921
SHR-9839 combined with pemetrexed + carboplatin
SHR-9839 ； pemetrexed ；carboplatin
SHR-9839 combined with pemetrexed + carboplatin
SHR-9839 combined with Almonertinib
SHR-9839 ； Almonertinib
SHR-9839 combined with Almonertinib
Interventions
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SHR-9839 ；SHR-A2009
SHR-9839 combined with SHR-A2009
SHR-9839 ； SHR-A1921
SHR-9839 combined with SHR-A1921
SHR-9839 ； pemetrexed ；carboplatin
SHR-9839 combined with pemetrexed + carboplatin
SHR-9839 ； Almonertinib
SHR-9839 combined with Almonertinib
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Hengrui Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Zhejiang Cancer Hospital
Zhejiang, HangZhou, China
HeNan CANCER HOSPITAL
Zhenzhou, Henan, China
Countries
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Central Contacts
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Other Identifiers
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SHR-9839-201
Identifier Type: -
Identifier Source: org_study_id
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