Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT06618651

Reclutamento in corso

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

Interventistico

Fase 1

West China Hospital of Sichuan Hospital

Sponsor: Suncadia Biopharmaceuticals

Ultimo Aggiornamento: 17 novembre 2025
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

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.

Categoria di Trattamento

Altri Farmaci

Mutazioni richieste

Nessuno

Studio Iniziato

13 novembre 2024

Ultimo Aggiornamento dello Sponsor

17 novembre 2025

Completamento Stimato

1 gennaio 2026

Contatto dello studio

Nome:Bin bai

Email:bin.bai@hengrui.com

Telefono:+86 15618539080

Nome:Hao Shen

Email:hao.shen@hengrui.com

Telefono:+86 021-61053363

Idoneità

Criteri di Inclusione

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.

Criteri di Esclusione

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.

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Dettagli del Disegno

AllocazioneN/A

Modello di InterventoSingle Group Assignment

MascheramentoNone (Open Label)

Numero da Arruolare162

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione:

Interventi:

SHR-3821 injection

Misure di Esito

Misure di Esito Primarie

DLT3 weeks

AEScreening up to study completion, an average of 1 year

MTD3 weeks

RP2DScreening up to study completion, an average of 1 year

Misure di Esito Secondarie

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

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Siti dello Studio

Questo studio ha 1 sito

West China Hospital of Sichuan Hospital

Chengdu, Sichuan, CN

Nome:Jiankun Hu

In fase di reclutamento

Chengdu, Sichuan, 610000 CN

West China Hospital of Sichuan Hospital

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