To hear about similar clinical trials, please enter your email below
Trial Title:
SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor
NCT ID:
NCT06350006
Condition:
Cldn18.2-positive Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This study is a multicenter Phase Ib/III clinical study. Phase Ib consists of two phases,
IB-A for dose escalation and IB-B for efficacy extension. The Phase III multi-center,
randomized controlled, double-blind study was designed to evaluate the efficacy and
safety of SHR-A1904 combined chemotherapy and immunotherapy versus chemotherapy combined
immunotherapy in first-line treatment of CLDN18.2-positive solid tumors patients.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1904; Adebrelimab
Description:
SHR-A1904 combined with Adebrelimab: SHR-A1904+ Adebrelimab
Arm group label:
SHR-A1904 combined with Adebrelimab
Intervention type:
Drug
Intervention name:
SHR-A1904; CAPOX; Adebrelimab
Description:
SHR-A1904 combined with Adebrelimab and CAPOX (Capecitabine, Oxaliplatin)
Arm group label:
SHR-A1904 combined with CAPOX and Adebrelimab
Summary:
This study consists of two research phases:
Phase Ib (includes dose escalation phase and efficacy extension phase): To explore the
safety, tolerability and initial efficacy of SHR-A1904 in the treatment of
CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and
recommended population for the Phase III combination study.
Phase III: A randomized, double-blind, multicenter clinical study of SHR-1904 combined
with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for
CLDN18.2-positive advanced solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18 to 75 years old (including boundary values);
2. Volunteer to participate in this clinical study and sign informed consent;
3. ECOG score 0-1;
4. Expected survival ≥3 months;
5. Pathologically confirmed locally advanced unresectable or metastatic solid tumors;
6. positive CLDN18.2 expression in tumor tissue;
7. There is at least one measurable lesion that meets the RECIST 1.1 criteria;
8. Adequate bone marrow and organ function.
Exclusion Criteria:
1. Plan to receive any other antitumor therapy during this trial; Received other
investigational drugs or treatments that are not on the market within 4 weeks prior
to the first administration; Anti-tumor therapy, such as chemotherapy, radiotherapy,
biotherapy, targeted therapy or immunotherapy, was received within 4 weeks before
the first administration of the study drug. Palliative radiotherapy or local therapy
within 2 weeks before the first administration of the study drug; Had major surgery
other than diagnosis or biopsy within the 4 weeks prior to the first administration
or randomization and required elective surgery during the trial.
2. Stage III: HER2 expression in tumor tissue is positive.
3. The adverse reactions of previous anti-tumor therapy has not recovered to NCI-CTCAE
v5.0 grade≤ 1.
4. Has ≥ grade 2 peripheral sensory neuropathy.
5. Has an allergic reaction to any of the components treated in this study, or are
allergic to humanized monoclonal antibody products.
6. Has a history or current history of meningeal metastasis; or active brain
metastases.
7. Presence of dysphagia or other factors affecting the use of oral medications.
8. Additional malignancy within the five years prior to the first administration or
randomization.
9. Has an active autoimmune disease or a history of autoimmune disease.
10. Received systemic use of corticosteroids or other immunosuppressants for
immunosuppressive effects within 14 days prior to the first administration or
randomization.
11. Has a history of clinically significant lung disease.
12. Has serosal effusion ≥ grade 3 (based on NCI CTCAE5.0 criteria).
13. There was an active infection requiring systemic treatment within 2 weeks prior to
the first administration or randomization.
14. A history of immunodeficiency, including a positive HIV test; Presence of active
hepatitis B or hepatitis C.
15. People who have previously received allogeneic hematopoietic stem cell
transplantation or organ transplantation.
16. Has severe cardiovascular and cerebrovascular diseases.
17. Gastrointestinal perforation and/or gastrointestinal fistula within the last 6
months prior to the first administration or randomization; Active gastrointestinal
bleeding occurred 3 months before the first administration or randomization.
18. In the investigator's judgment, the subjects has other factors that could have
affected the study results or led to the forced termination of the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Ruihua Xu
Start date:
May 29, 2024
Completion date:
December 30, 2028
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/NCT06350006
