Übersicht

Eignung

Details zum Design

Arme & Interventionen

Ergebnismessungen

Studienzentren

Quelle: NCT06618651

Rekrutiert

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

Interventionsstudie

Phase 1

West China Hospital of Sichuan Hospital

Sponsor: Suncadia Biopharmaceuticals

Zuletzt aktualisiert: 17. November 2025
Hinweis - Die Informationen stammen aus öffentlichen Registern und spiegeln möglicherweise nicht die Echtzeitänderungen am lokalen Studienzentrum wider.

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.

Behandlungskategorie

Andere Medikamente

Erforderliche Mutationen

Keine

Studie gestartet

13. November 2024

Zuletzt vom Sponsor aktualisiert

17. November 2025

Voraussichtlicher Abschluss

1. Januar 2026

Studienkontakt

Name:Bin bai

E-Mail:bin.bai@hengrui.com

Telefon:+86 15618539080

Name:Hao Shen

E-Mail:hao.shen@hengrui.com

Telefon:+86 021-61053363

Eignung

Einschlusskriterien

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.

Ausschlusskriterien

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.

Glauben Sie, dass diese klinische Studie fälschlicherweise angezeigt wird?

Design-Details

ZuteilungN/A

InterventionsmodellSingle Group Assignment

MaskierungNone (Open Label)

Anzahl der Teilnehmer162

Arme & Interventionen

Arme

Interventionen

Typ: Experimental

Beschreibung:

Interventionen:

SHR-3821 injection

Ergebnismessungen

Primäre Ergebnismessungen

DLT3 weeks

AEScreening up to study completion, an average of 1 year

MTD3 weeks

RP2DScreening up to study completion, an average of 1 year

Sekundäre Ergebnismessungen

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

Studie vormerken

Studie teilen

Studie herunterladen

Glauben Sie, dass diese klinische Studie fälschlicherweise angezeigt wird?

Studie melden

Studie herunterladen

Studienzentren

Diese Studie hat 1 Studienzentrum

West China Hospital of Sichuan Hospital

Chengdu, Sichuan, CN

Name:Jiankun Hu

Rekrutierend

Chengdu, Sichuan, 610000 CN

West China Hospital of Sichuan Hospital

Loading Maps...