Panoramica

Idoneità

Dettagli del Disegno

Bracci e Interventi

Misure di Esito

Siti dello Studio

Fonte: NCT07092748

Reclutamento in corso

A Phase Ia/ Ib Study of HS387 in Subjects With Advanced Solid Tumors

Interventistico

Fase 1

Zhejiang Cancer hospital

Sponsor: Zhejiang Hisun Pharmaceutical

Ultimo Aggiornamento: 30 luglio 2025
Avviso - Le informazioni provengono da registri pubblici e potrebbero non riflettere i cambiamenti in tempo reale presso il centro locale.

This is a Phase Ia/Ib, dose escalation and dose expansion study to evaluate the safety, tolerability, PK, and preliminary efficacy of HS387 in subjects with advanced solid tumors. It includes two parts: the dose escalation study (Phase Ia) and the dose expansion study (Phase Ib)

Categoria di Trattamento

Altri Farmaci

Mutazioni richieste

Nessuno

Studio Iniziato

15 luglio 2025

Ultimo Aggiornamento dello Sponsor

30 luglio 2025

Completamento Stimato

30 giugno 2028

Contatto dello studio

Nome:WEI QU

Email:wei.qu@hisunpharm.com

Telefono:8618067913551

Idoneità

Criteri di Inclusione

* Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:

1. Men or women ≥18 years old and ≤75 years old.

2. Subjects with advanced solid tumors who have failed or are intolerant to standard treatment, or have no standard therapy.

3. Survival expectation is ≥ 3 months.

4. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.

5. Phase Ⅰa: Subjects with advanced solid tumors have at least one evaluable lesion according to RECIST 1.1. Phase Ⅰb: Subjects with advanced solid tumors have at least one measurable lesion according to RECIST 1.1.

6. Subjects with adequate organ function at the time of screening.

7. Serum pregnancy test (for female of childbearing potential) negative prior to first dosing of study treatment. Male and female subjects of childbearing potential must agree to use effective methods of contraception throughout the study and for 3 months after the last dose of the investigational product.

Criteri di Esclusione

* Subjects will be excluded if they meet any of the following criteria:

1. Has received other investigational drugs or treatments not yet approved for marketing within 4 weeks prior to the first administration.

2. Has active infection.

3. Has meningeal metastases or symptomatic central nervous system (CNS) metastases.

4. Significant impairment of oral drug absorption.

5. Has interstitial lung disease.

6. Pregnant or lactating women.

7. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.

8. Has a major surgical procedure within 4 weeks prior to the first administration.

9. Has a treatment history of KIF18A inhibitor.

10. In the opinion of the Investigator, there are other factors that the subject is unsuitable for participation in this clinical study.

Pensi che questo studio appaia erroneamente?

Dettagli del Disegno

AllocazioneN/A

Modello di InterventoSingle Group Assignment

MascheramentoNone (Open Label)

Numero da Arruolare110

Bracci e Interventi

Bracci

Interventi

Tipo: Experimental

Descrizione:

Interventi:

HS387

Misure di Esito

Misure di Esito Primarie

Dose-limiting Toxicities Incidence Count Among Study Participant2 years

DLT refers to Dose-Limiting Toxicity. It is defined as a side effect or adverse reaction of a drug or treatment that is severe enough to prevent an increase in dosage. Identifying DLT is crucial in clinical trials for determining the maximum tolerated dose (MTD) of a new drug.

Number of Participants Reporting Adverse Events (AEs) or Serious Adverse Events (SAEs)2 years

Adverse events (AE), serious adverse events (SAE), and severity of AE using the NCI-CTCAE version 5.0

Misure di Esito Secondarie

Nessuno

Aggiungi studio ai preferiti

Condividi Studio

Scarica lo studio

Pensi che questo studio appaia erroneamente?

Segnala Studio

Scarica lo studio

Siti dello Studio

Questo studio ha 1 sito

Zhejiang Cancer hospital

Hangzhou, Zhejiang, CN

Nome:Zhengbo Song, doctorate

In fase di reclutamento

Hangzhou, Zhejiang, CN

Zhejiang Cancer hospital

Loading Maps...