Clinical trial NCT05594875: A Trial of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors
Official title: An Open-Label, Multi-Center Phase I Clinical Study on the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-A1921 for Injection in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Atridia Pty Ltd.
Sponsor class: INDUSTRY
First posted: 2022-10-26
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: SHR-1921 single arm study in pt. with Advance solid tumors
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of SHR-1921.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of subjects with adverse events (AEs)
timeFrame: Screening up to study completion, an average of 1 year
measure: Number of subjects with laboratory tests findings of potential clinical importance
timeFrame: Screening up to study completion, an average of 1 year
measure: Incidence of vital sign abnormalities e.g. Systolic and Diastolic BP, Pulse rate.
timeFrame: Screening up to study completion, an average of 1 year
measure: Measure ECG
timeFrame: Screening up to study completion, an average of 1 year
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax) of SHR-1921
timeFrame: Screening up to study completion, an average of 1 year
measure: Area under the concentration-time curve (AUC 0-∞) from time 0 to infinity of SHR-1921
timeFrame: Screening up to study completion, an average of 1 year
measure: Time to Cmax (Tmax) of SHR-1921
timeFrame: Screening up to study completion, an average of 1 year
measure: Clearance of SHR-1921
timeFrame: Screening up to study completion, an average of 1 year
measure: Terminal elimination half-life (t1/2) of SHR-1921
timeFrame: Screening up to study completion, an average of 1 year
measure: Pharmacodynamics ("ADA" ) of SHR-1921.
timeFrame: Screening up to study completion, an average of 1 year
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Scientia Clinical Research
state: New South Wales
city: Sydney
country: Australia
facility: Macquarie Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Sydney South West Private Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: ICON Cancer Centre
state: Queensland
Study officials:
References: