To hear about similar clinical trials, please enter your email below
Trial Title:
A Phase IB/II Clinical Study of SHR-A2009 for Injection in Combination With Other Antitumor Therapies in Patients With Advanced Solid Tumors
NCT ID:
NCT06092268
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
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-A2009 for injection ； Almonertinib Mesilate Tablets
Description:
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.
Arm group label:
Treatment Part A: SHR-A2009 for injection in combination with Almonertinib Mesilate Tablets
Intervention type:
Drug
Intervention name:
SHR-A2009 for injection；Adebrelimab Injection
Description:
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.
Arm group label:
Treatment Part B: SHR-A2009 for injection in combination with Adebrelimab Injection
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.
Criteria for eligibility:
Criteria:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
October 2023
Completion date:
December 2025
Lead sponsor:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06092268
