A Study of SHR-3821 Injection in Subjects With Advanced Solid Tumors
- 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.
- Short title
- A Study of SHR-3821 Injection in Subjects With Advanced Solid Tumors
- Official title
- Phase I Study of Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-3821 Injection in Subjects With Advanced Solid Tumors
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-01-01
- First posted
- 2024-10-01
- Registry last updated
- 2025-11-17
- Primary completion date
- 2026-01-01
- Start date
- 2024-11-13
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Suzhou Suncadia Biopharmaceuticals Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06618651
- ClinicalTrials.gov ID
- NCT06618651
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
DLT
Timeframe: 3 weeks
AE
Timeframe: Screening up to study completion, an average of 1 year
MTD
Timeframe: 3 weeks
RP2D
Timeframe: Screening up to study completion, an average of 1 year
Blood concentration of SHR-3821 after single and continuous administration
Timeframe: Screening up to study completion, an average of 1 year
PK parameters of SHR-3821 after single and continuous administration: Tmax
Timeframe: Screening up to study completion, an average of 1 year
PK parameters of SHR-3821 after single and continuous administration: Cmax
Timeframe: Screening up to study completion, an average of 1 year
PK parameters of SHR-3821 after single and continuous administration: AUC0-t
Timeframe: Screening up to study completion, an average of 1 year
Drug Resistant Antibody (ADA) to SHR-3821
Timeframe: Screening up to study completion, an average of 1 year
Objective response rate (ORR)
Timeframe: Screening up to study completion, an average of 1 year
Disease control rate (DCR)
Timeframe: Screening up to study completion, an average of 1 year
Progression-free survival (PFS)
Timeframe: Screening up to study completion, an average of 1 year
Overall survival (OS)
Timeframe: Screening up to study completion, an average of 1 year
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- Voluntary participation and written informed consent.
- 18-75 years older, no gender limitation.
- Eastern Cooperative Oncology Group (ECOG) score: 0-1.
- 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 v1.1.
- Adequate bone marrow reserve and organ function.
- Contraception is required during the trial.
- 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-3821.
- Active hepatitis B or active hepatitis C.
- Other inappropriate situation considered by the investigator.
- West China Hospital of Sichuan HospitalChengdu, ChinaRecruiting