Tumor Clinical Trial
Official title:
A Phase Ⅰa Clinical Study Exploring Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of SIBP-03 When Treating the Patients With Advanced Malignant Solid Tumors.
The main purpose of • To evaluate the safety, tolerability and pharmacokinetic characteristics of SIBP-03(Recombinant anti-HER3 humanized monoclonal antibody injection). A secondary purpose - Assess the immunogenicity of SIBP-03. Exploratory purpose - Explore potential biomarkers; - Preliminary evaluation of the antitumor efficacy of SIBP-03.
To evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of recombinant anti-HER3 humanized monoclonal antibody injection when treating the patients with advanced malignant solid tumors. This study is an open, multi-dose escalation and extension study of single and multiple dosing. This study was divided into two phases: the first phase was dose escalation phase, the second phase was joint expansion phase, in which the dose escalation phase was a single-center study, and the joint expansion phase was a multi-center study. Stage 1, dose escalation stage: Six dose groups of 2, 5, 10, 15, 20 and 40 mg/kg were planned, then exploring the most appropriate dose. The second stage, combined use extension stage: According to the preliminary data of drug safety, tolerance, pharmacokinetics and efficacy obtained in the dose escalation stage, combined with the clinical study results of similar drugs, 5mg/kg and 10mg/kg dose levels were selected to enter the combined extension stage and used in patients with advanced head and neck squamous cell carcinoma or with breast cancer. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04848376 -
Post-Market Clinical Follow-up Study of A-SPINE's Products
|
||
Active, not recruiting |
NCT05470283 -
Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma
|
Phase 1 | |
Completed |
NCT05041920 -
A Drug-drug Interaction Study of Famitinib Malate With a Proton Pump Inhibitor in Healthy Adult Subjects
|
Phase 1 | |
Recruiting |
NCT04430361 -
the Efficacy and Safety of 5-HT3 Receptor Antagonist, Dexamethasone or Megestrol Acetate Dispersible Tablets in the Control of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
|
Phase 2 | |
Not yet recruiting |
NCT05549557 -
IMM40H Phase I Dose Escalation and Expansion
|
Phase 1 | |
Not yet recruiting |
NCT05443854 -
Impact of Aminoglycosides-based Antibiotics Combination and Protective Isolation on Outcomes in Critically-ill Neutropenic Patients With Sepsis: (Combination-Lock01)
|
Phase 3 | |
Completed |
NCT01946555 -
Prospective Longitudinal Observational Study to Evaluate the Clinical Characteristics and Opioids Treatments in Patients With Breakthrough Cancer Pain
|
N/A | |
Terminated |
NCT01846429 -
Oral Bicarbonate as Adjuvant for Pain Reduction in Patients With Tumor Related Pain
|
Phase 1 | |
Recruiting |
NCT01093079 -
Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes
|
N/A | |
Recruiting |
NCT01387971 -
Using Impression Cytology to Observe the Cytological Changes of Ocular Surface Cells in Various Ocular Surface Disorders
|
N/A | |
Recruiting |
NCT00690261 -
The Impact of M1/M2 Tumor Associated Macrophage (TAM) Polarization on Cancer Progression and Prognosis Prediction
|
N/A | |
Completed |
NCT00561795 -
Feasibility Study of Pazopanib in Combination With Chemotherapy in Gynaecological Tumors
|
Phase 2 | |
Completed |
NCT00413322 -
Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors
|
Phase 1 | |
Completed |
NCT00152659 -
Developing Criteria for Cortical Resections
|
||
Completed |
NCT00777751 -
Radiation Therapy and Cardiac Enzymes
|
N/A | |
Not yet recruiting |
NCT06109896 -
Clinical Stories and Psychological Experiences of Cancer Patients
|
||
Not yet recruiting |
NCT05879146 -
Evaluation of the Response and Non-response of Nirogacestat in Desmoid Tumors- Clinical Study
|
Phase 2 | |
Recruiting |
NCT02810405 -
Collection of Tissue Blocks or Slides From Patients With Cancer
|
||
Recruiting |
NCT01867268 -
Effect of Acetazolamide & Position in CSF Leakage and Collection and Wound Dehiscence
|
Phase 2 | |
Terminated |
NCT01720745 -
Comparison of "Wet Suction" Technique to Contemporary "Dry Suction" Technique Using a 22 Gauge Needle for EUS FNA
|