Clinical trial NCT06618651: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Voluntary participation and written informed consent.
2. 18-75 years older, no gender limitation.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
4. With a life expectancy ≥ 3 months.
5. Pathologically diagnosed advanced solid tumor.
6. Be able to provide fresh or archived tumour tissue.
7. At least one measurable lesion according to RECIST v1.1.
8. Adequate bone marrow reserve and organ function.
9. Contraception is required during the trial.

Exclusion Criteria:

1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis.
2. Uncontrollable tumor-related pain.
3. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms.
4. Received systemic antitumor therapy before the first dose.
5. Treated with similar target therapy as SHR-3821 before the first dose.
6. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment.
7. Unresolved CTCAE 5.0\>=grade 2 toxicities from previous anticancer therapy.
8. Current or History of ILD.
9. Active severe digestive disease.
10. Previous or co-existing malignancies.
11. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-3821.
12. Active hepatitis B or active hepatitis C.
13. Other inappropriate situation considered by the investigator.

Primary outcomes:
measure: DLT
timeFrame: 3 weeks
measure: AE
timeFrame: Screening up to study completion, an average of 1 year
measure: MTD
timeFrame: 3 weeks
measure: RP2D
timeFrame: Screening up to study completion, an average of 1 year
Secondary outcomes:
measure: Blood concentration of SHR-3821 after single and continuous administration
timeFrame: Screening up to study completion, an average of 1 year
measure: PK parameters of SHR-3821 after single and continuous administration: Tmax
timeFrame: Screening up to study completion, an average of 1 year
measure: PK parameters of SHR-3821 after single and continuous administration: Cmax
timeFrame: Screening up to study completion, an average of 1 year
measure: PK parameters of SHR-3821 after single and continuous administration: AUC0-t
timeFrame: Screening up to study completion, an average of 1 year
measure: Drug Resistant Antibody (ADA) to SHR-3821
timeFrame: Screening up to study completion, an average of 1 year
measure: Objective response rate (ORR)
timeFrame: Screening up to study completion, an average of 1 year
measure: Disease control rate (DCR)
timeFrame: Screening up to study completion, an average of 1 year
measure: Progression-free survival (PFS)
timeFrame: Screening up to study completion, an average of 1 year
measure: Overall survival (OS)
timeFrame: Screening up to study completion, an average of 1 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital of Sichuan Hospital
state: Sichuan
Study officials:
References: