Advanced Solid Tumor
Conditions
Brief summary
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-1921.
Interventions
DRUGSHR-1921
Subject will receive a single dose of SHR-1921 at dose level 1/2/3 on Day of each cycles
Sponsors
Atridia Pty Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SHR-1921 single arm study in pt. with Advance solid tumors
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent 2. Subjects consented and willing to provide required tumor tissue of sufficient quantity and of adequate tumor tissue content 3. Male or female 4. Subjects with clinically or pathologically confirmed advanced (recurrent, unresectable or metastatic) solid tumors who have failed prior standard of care therapy 5. ECOG performance status of 0-1
Exclusion criteria
1. Has uncontrolled clinically symptomatic pleural effusion, pericardial effusion, carcinomatous ascites 2. Has untreated brain metastasis, or with concomitant meningeal metastasis or spinal cord compression 3. Has known history of other documented malignancy 4. Has known history of acquired immunodeficiency syndrome (AIDS) 5. Has significant cardiovascular disease that is not well controlled, such as: (1) New York Heart Association (NYHA) Grade ≥ 2 cardiac failure 6. Has active or prior documented interstitial pneumonia/interstitial lung disease 7. Has experienced Grade ≥ 2 hemorrhage events within 4 weeks prior to the first dose 8. Has known active hepatitis B 9. Has known allergies to SHR-1921 component 10. Has other potential factors that may interfere with the study results, or result in the premature discontinuation as determined by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events (AEs) | Screening up to study completion, an average of 1 year | To check the numbers of AEs happened during the course of trial. |
| Number of subjects with laboratory tests findings of potential clinical importance | Screening up to study completion, an average of 1 year | To check the Clinically significant and non clinically significant abnormal values during the course of trial. |
| Incidence of vital sign abnormalities e.g. Systolic and Diastolic BP, Pulse rate. | Screening up to study completion, an average of 1 year | To measure the vital signs on regular basis for all study participants |
| Measure ECG | Screening up to study completion, an average of 1 year | Number of subjects with clinically significant abnormal ECG QT Interval |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Terminal elimination half-life (t1/2) of SHR-1921 | Screening up to study completion, an average of 1 year | To check how much time SHR-1921 will take to eliminate half of it's concentration from participants. |
| Maximum observed plasma concentration (Cmax) of SHR-1921 | Screening up to study completion, an average of 1 year | To check what will be the maximum concentration participants will obtained of SHR-1921 in their blood plasma. |
| Pharmacodynamics (ADA ) of SHR-1921. | Screening up to study completion, an average of 1 year | To check the Anti Drug Antibody develops in participants against the SHR-1921 through blood sample |
| Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of SHR-1921 | Screening up to study completion, an average of 1 year | To check the drug profile for absorption, distribution, metabolism and excretion for SHR-1921 in participants blood plasma |
| Time to Cmax (Tmax) of SHR-1921 | Screening up to study completion, an average of 1 year | To check what time will it take to reach the maximum contraction of SHR-1921 in study participants |
| Clearance of SHR-1921 | Screening up to study completion, an average of 1 year | The apparent clearance of SHR-1921(CL/F) of SHR-1921 |
Countries
Australia
Outcome results
None listed