NCT06618651RecruitingPhase 1
Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-3821 Injection in Subjects With Advanced Solid Tumors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country162 target enrollmentStarted: November 13, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- DLT
Study Overview
Brief Summary
This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Voluntary participation and written informed consent.
- •18-75 years older, no gender limitation.
- •Eastern Cooperative Oncology Group (ECOG) score: 0-
- •With a life expectancy ≥ 3 months.
- •Pathologically diagnosed advanced solid tumor.
- •Be able to provide fresh or archived tumour tissue.
- •At least one measurable lesion according to RECIST v1.
- •Adequate bone marrow reserve and organ function.
- •Contraception is required during the trial.
Exclusion Criteria
- •Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
- •Uncontrollable tumor-related pain.
- •Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
- •Received systemic antitumor therapy before the first dose.
- •Treated with similar target therapy as SHR-3821 before the first dose.
- •Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
- •Unresolved CTCAE 5.0>=grade 2 toxicities from previous anticancer therapy.
- •Current or History of ILD.
- •Active severe digestive disease.
- •Previous or co-existing malignancies.
- •History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-
- •Active hepatitis B or active hepatitis C.
- •Other inappropriate situation considered by the investigator.
Arms & Interventions
SHR-3821 injection
Experimental
Intervention: SHR-3821 injection (Drug)
Outcomes
Primary Outcomes
DLT
Time Frame: 3 weeks
AE
Time Frame: Screening up to study completion, an average of 1 year
MTD
Time Frame: 3 weeks
RP2D
Time Frame: Screening up to study completion, an average of 1 year
Secondary Outcomes
- PK parameters of SHR-3821 after single and continuous administration: AUC0-t(Screening up to study completion, an average of 1 year)
- Drug Resistant Antibody (ADA) to SHR-3821(Screening up to study completion, an average of 1 year)
- Blood concentration of SHR-3821 after single and continuous administration(Screening up to study completion, an average of 1 year)
- PK parameters of SHR-3821 after single and continuous administration: Tmax(Screening up to study completion, an average of 1 year)
- PK parameters of SHR-3821 after single and continuous administration: Cmax(Screening up to study completion, an average of 1 year)
- Objective response rate (ORR)(Screening up to study completion, an average of 1 year)
- Disease control rate (DCR)(Screening up to study completion, an average of 1 year)
- Progression-free survival (PFS)(Screening up to study completion, an average of 1 year)
- Overall survival (OS)(Screening up to study completion, an average of 1 year)
Investigators
Study Sites (1)
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