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Trial Title:
A Clinical Study of SHR-3276 for Injection in Patients With Advanced Malignant Tumors
NCT ID:
NCT06643754
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:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Single arm study of SHR-3276
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-3276
Description:
Dose Escalation: SHR-3276 will be administered intravenously. 4 dose levels are preset.
Dose Expansion: 2 to 3 dose cohorts will be selected for dose expansion stage.
Indication Expansion: Indications will be selected to evaluate preliminary efficacy.
Arm group label:
SHR-3276 for Injection will be administrated per dose level in which the patients are assigned.
Summary:
This study is an open-label, multicenter Phase I/II clinical trial to evaluate the
safety, tolerability, pharmacokinetics and efficacy of SHR-3276 for injection in patients
with advanced solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Able and willing to sign a written informed consent；
2. Age 18-70 years old (including both ends), both male and female；
3. Pathologically confirmed advanced malignant tumors that have failed sufficient
standard treatment or have no effective standard treatment plan；
4. Existence of measurable lesions；
5. ECOG score: 0-1；
6. Expected survival time ≥ 12 weeks；
7. The functional level of the major organs must meet the requirements；
8. Fertile female patients must have a serum pregnancy test within 7 days before the
first medication and the result is negative; And must be non-lactating.
Exclusion Criteria:
1. Central nervous system metastasis or meningeal metastasis with clinical symptoms;
2. Spinal cord compression that has not been treated radically by surgery and/or
radiotherapy；
3. Patients with uncontrolled tumor-related pain as judged by the investigator
4. A third space effusion with uncontrolled pleural effusion, pericardial effusion, or
peritoneal effusion, as determined by the investigator；
5. Systemic antitumor therapy was administered within 28 days prior to treatment in the
first study；
6. Surgical procedures requiring tracheal intubation and general anesthesia were
performed within 28 days prior to the initial study, or elective surgery was
expected during the trial period；
7. Serious drug-related adverse reactions during previous immune checkpoint inhibitor
therapy；
8. Has unresolved toxicities from previous anticancer therapy, defined as toxicities
not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1；
9. Live attenuated vaccines were used within 28 days prior to administration in the
first study or were expected to be required during the study treatment；
10. Systemic immunosuppressive therapy was administered within 14 days prior to the
first study
11. Arterial/venous thrombosis events occurred within 3 months prior to initial
administration
12. Patients with clinical significant lung disease;
13. Patients with history of autoimmune diseases;
14. The first study studied any other malignancy within 5 years prior to medication
15. A known history of severe allergic reactions to the investigational drug and its
principal formulation ingredients；
16. Have a history of immune deficiency or organ transplantation；
17. Other serious accompanying illnesses, which, in the investigator's assessment, could
seriously adversely affect the safety of the treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Second Affiliated Hospital of PLA Army Medical University
Address:
City:
Chongqing
Zip:
400037
Country:
China
Contact:
Last name:
Bo Zhu
Start date:
October 25, 2024
Completion date:
December 30, 2028
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/NCT06643754
