Aperçu

Éligibilité

Détails de la conception

Bras et interventions

Mesures des résultats

Sites d'essai

Source : NCT06618651

Recrutement en cours

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

Interventionnel

Phase 1

West China Hospital of Sichuan Hospital

Sponsor: Suncadia Biopharmaceuticals

Dernière synchronisation : 17 novembre 2025
Avis - Les informations proviennent de registres publics et peuvent ne pas refléter les changements en temps réel sur le site 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.

Catégorie de traitement

Autres médicaments

Mutations requises

Aucun

Essai commencé

13 novembre 2024

Dernière mise à jour par le sponsor

17 novembre 2025

Achèvement estimé

1 janvier 2026

Contact de l'étude

Nom:Bin bai

E-mail:bin.bai@hengrui.com

Téléphone:+86 15618539080

Nom:Hao Shen

E-mail:hao.shen@hengrui.com

Téléphone:+86 021-61053363

Éligibilité

Critères d'inclusion

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.

Critères d'exclusion

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.

Pensez-vous que cet essai apparaît incorrectement ?

Détails de la conception

AllocationN/A

Modèle d'interventionSingle Group Assignment

MasquageNone (Open Label)

Nombre à inscrire162

Bras et interventions

Bras

Interventions

Type : Experimental

Description :

Interventions :

SHR-3821 injection

Mesures des résultats

Mesures des résultats primaires

DLT3 weeks

AEScreening up to study completion, an average of 1 year

MTD3 weeks

RP2DScreening up to study completion, an average of 1 year

Mesures des résultats secondaires

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

Mettre l'essai en favori

Partager l'essai

Télécharger l'essai

Pensez-vous que cet essai apparaît incorrectement ?

Signaler l'essai

Télécharger l'essai

Sites d'essai

Cette étude compte 1 site d'essai

West China Hospital of Sichuan Hospital

Chengdu, Sichuan, CN

Nom:Jiankun Hu

Recrutement en cours

Chengdu, Sichuan, 610000 CN

West China Hospital of Sichuan Hospital

Loading Maps...