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Trial Title:
Study of SHR-A1921 in Combination With Other Anti-cancer Agents in Patients With Advanced Solid Tumors
NCT ID:
NCT05765032
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1921；
Description:
Drug: SHR-A1921 administered as an IV infusion Drug: Adebrelimab administered as an IV
infusion Drug: Carboplatin administered as an IV infusion Drug: Cisplatin administered as
an IV infusion Drug: Bevacizumab administered as an IV infusion
Arm group label:
SHR-A1921
Summary:
This research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety
of SHR-A1921 in combination with other anti-cancer agents in patients with advanced solid
tumors
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female, 18-75 years;
2. Be able to provide fresh or archived tumour tissue.
3. Ph 1b: clinically or pathologically diagnosed advanced solid tumour . Ph II:
Histologically or cytologically confirmed, advanced or metastatic non-small cell
lung cancer
4. With at least one measurable lesion (in accordance with RECIST v1.1)
5. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
6. With a life expectancy ≥ 12 weeks.
7. Sufficient organ functions.
8. Women of childbearing potential (WOCBP) and Male subjects whose partner are women of
childbearing potential must agree to use a reliable and valid contraceptive method.
Exclusion Criteria:
1. Untreated brain metastasis or accompanied by meningeal metastases, spinal cord
compression.
2. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with
clinical symptoms.
3. Previous or co-existing malignancies other than cured basal cell carcinoma of the
skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast (DCIS),
papillary thyroid carcinoma, and other malignancies that have been adequately
treated and cured for ≥3 years
4. Hypertension that can not be well controlled through antihypertensive drugs
(systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); previous
hypertensive crisis or hypertensive encephalopathy.
5. with any active or known autoimmune disease
6. with active pulmonary tuberculosis infection
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Tianjin Medical University Cancer Institute& Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Start date:
December 30, 2022
Completion date:
February 28, 2026
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/NCT05765032
