Resumen

Elegibilidad

Detalles del diseño

Brazos e Intervenciones

Medidas de resultado

Sitios del ensayo

Fuente: NCT06618651

Reclutando

A Study of SHR-3821 Injection in Subjects With Advanced Solid Tumors

Intervencionista

Fase 1

West China Hospital of Sichuan Hospital

Patrocinador: Suncadia Biopharmaceuticals

Última actualización: 17 de noviembre de 2025
Aviso: La información proviene de registros públicos y puede no reflejar cambios en tiempo real en el centro local.

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.

Categoría de tratamiento

Otros medicamentos

Erforderliche Mutationen

Ninguna

Ensayo iniciado

13 de noviembre de 2024

Última actualización por el patrocinador

17 de noviembre de 2025

Finalización estimada

1 de enero de 2026

Contacto del estudio

Nombre:Bin bai

Correo electrónico:bin.bai@hengrui.com

Teléfono:+86 15618539080

Nombre:Hao Shen

Correo electrónico:hao.shen@hengrui.com

Teléfono:+86 021-61053363

Elegibilidad

Criterios de inclusión

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.

Criterios de exclusión

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.

¿Cree usted que este ensayo clínico se muestra por error?

Detalles del diseño

AsignaciónN/A

Modelo de intervenciónSingle Group Assignment

EnmascaramientoNone (Open Label)

Número a inscribir162

Brazos e Intervenciones

Brazos

Intervenciones

Tipo: Experimental

Descripción:

Intervenciones:

SHR-3821 injection

Medidas de resultado

Medidas de resultado primarias

DLT3 weeks

AEScreening up to study completion, an average of 1 year

MTD3 weeks

RP2DScreening up to study completion, an average of 1 year

Medidas de resultado secundarias

Blood concentration of SHR-3821 after single and continuous administrationScreening up to study completion, an average of 1 year

PK parameters of SHR-3821 after single and continuous administration: TmaxScreening up to study completion, an average of 1 year

PK parameters of SHR-3821 after single and continuous administration: CmaxScreening up to study completion, an average of 1 year

PK parameters of SHR-3821 after single and continuous administration: AUC0-tScreening up to study completion, an average of 1 year

Drug Resistant Antibody (ADA) to SHR-3821Screening 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

Guardar ensayo

Compartir ensayo

Descargar ensayo

¿Cree usted que este ensayo clínico se muestra por error?

Reportar ensayo

Descargar ensayo

Sitios del ensayo

Este estudio tiene 1 sitio de ensayo

West China Hospital of Sichuan Hospital

Chengdu, Sichuan, CN

Nombre:Jiankun Hu

Reclutando

Chengdu, Sichuan, 610000 CN

West China Hospital of Sichuan Hospital

Loading Maps...