- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT06781567
Clinical Trial of HG146 Administered to Participants With Adenoid Cystic Carcinoma (HG146)
A Phase Il Clinical Study to Evaluate the Efficacy and Safety of HG146 Capsules in Participants With Recurrent or Metastatic Adenoid Cystic Carcinoma.
This is a Phase II, open-label, non-randomized, multicenter study to evaluate the clinical efficacy and safety of HG146 in participants with recurrent or metastatic adenoid cystic carcinoma. This study is divided into two stages. 40 participants will be enrolled in the first stage. The efficacy and safty data will apply to make go or no go decision. Then the second stage will continue to enroll 100 Particapants.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 2
Contatti e Sedi
Contatto studio
- Nome: Jie Shen
- Numero di telefono: 8211 8268-85197385
- Email: jie.shen@hitgen.com
Luoghi di studio
-
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Cina, 200000
- Reclutamento
- Shanghai Oriental Hospital
-
Contatto:
- Ye Guo
- Numero di telefono: 8268-85197385
- Email: pattrickguo@gmail.com
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Signed informed consent form (ICF) and able to comply with study.
- Age ≥18 years, gender unlimited.
- Recurrent or metastatic adenoid cystic carcinoma with evidence of disease progression (imaging progression or clinical evidence of progression) within one year of histological or cytological diagnosis.
- Estimated survival >12 weeks, as determined by the investigator.
- The United States Eastern Cancer Consortium (ECOG) physical status score 0-1.
- Has adequate organ function.
- At least 1 measurable tumor lesion according to RECISTv1.1 criteria.
Exclusion Criteria:
- Symptomatic central nervous system (CNS) metastases that have required steroids within 4 weeks prior to first dose of study treatment.
- Received prior therapies targeting HDAC.
- Chemotherapy was received within 21 days before the first administration of the study treatment, and anti-tumor therapy such as radiotherapy, biotherapy, targeted therapy, and immunotherapy was received within 28 days before the first administration of the study treatment [small molecule targeted drugs, Chinese medicines with anti-tumor indications, and local palliative radiotherapy were 14 times before the first administration of the study drug.
- Used strong CYP3A4 inhibitors or inducers within 7 days before the first use of the investigational drug.
- Major surgery or major injury <=28 days before the first dose of study treatment,or anticipated major surgery during the study.
- Prior allogeneic bone marrow transplantation or other solid organ transplantation
- Active infection requiring systemic treatment.
- Current or past presence of other malignancies (other than adequately treated basal cell or squamous cell carcinoma of the skin and carcinoma in situ of the cervix), unless radical treatment has been performed and there is no evidence of recurrence and metastasis in the last 5 years.
- A person is known to be allergic to any active ingredient or excipient of the investigational drug.
- Pregnant or lactating women.
- patients with drug abuse or chronic alcohol abuse that may affect the evaluation of the test results.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Clinical Trial of HG146 Administered to participants with Adenoid cystic carcinoma
Experimental: HG146 Monotherapy Arm Description: Participants will receive HG146 per os at every two days intervals (qod) for 14 consecutive days,7 days off, 21 days/ cycle. |
HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
objective response rate (ORR)
Lasso di tempo: From enrollment to the end of treatment at 4 weeks
|
ORR will be assessed by the investigators using RECIST v1.1 |
From enrollment to the end of treatment at 4 weeks
|
|
6 Months Progression-Free Survival (PFS)
Lasso di tempo: From enrollment to treatment at 6 months.
|
PFS will be assessed by the investigators using RECIST v. 1.1 |
From enrollment to treatment at 6 months.
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Progression-Free Survival (PFS)
Lasso di tempo: From enrollment to treatment at 12 months
|
PFS will be assessed by the investigators using RECIST v1.1 |
From enrollment to treatment at 12 months
|
|
Duration of response (DoR)
Lasso di tempo: From enrollment to the end of treatment at 4 weeks
|
DOR will be assessed by the investigators using RECIST v1.1 |
From enrollment to the end of treatment at 4 weeks
|
|
Disease control rate (DCR)
Lasso di tempo: From enrollment to the end of treatment at 4 weeks
|
DCR will be assessed by the investigators using RECIST v1.1 |
From enrollment to the end of treatment at 4 weeks
|
|
Overall survival (OS)
Lasso di tempo: From enrollment to the end of treatment at 4 weeks
|
OS will be assessed by the investigators |
From enrollment to the end of treatment at 4 weeks
|
|
Time-to-response (TTR)
Lasso di tempo: From enrollment to the end of treatment at 4 weeks
|
TTR will be assessed by the investigators using RECIST v1.1 |
From enrollment to the end of treatment at 4 weeks
|
|
Population pharmacokinetics (PopPK)
Lasso di tempo: From Cycle1 Day7 to Day13, 21 days per cycle
|
PopPK will be detected to predict exposure level of HG146 in human body. |
From Cycle1 Day7 to Day13, 21 days per cycle
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ye Guo, Shanghai Oriental Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- HG146CN201
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .