Evaluation of RAS Inhibitor Treatment in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
A Phase I, Multi-center, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of ASKC189 in Chinese Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors Carrying RAS Gene Mutations.
This is a phase I study to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of ASKC189 in in Participants With Advanced or Metastatic Solid Tumors Harboring RAS Mutations
Přehled studie
Typ studie
Zápis (Odhadovaný)
Fáze
- Fáze 1
Kontakty a umístění
Studijní kontakt
- Jméno: Jiangsu Aosaikang Study Director
- Telefonní číslo: +86 025 52169999
- E-mail: ctr-contact@ask-pharm.com
Studijní místa
-
-
-
Beijing, Čína
- Peking University Cancer Hospital
-
Vrchní vyšetřovatel:
- Lin Shen, MD
-
Shanghai, Čína
- Shanghai East Hospital
-
Vrchní vyšetřovatel:
- Caicun Zhou, MD
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Aged ≥18 years old at the time of informed consent
- Able to provide informed consent voluntarily before any study-related activities and according to local guidelines
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Have an estimated life expectancy ≥ 12 weeks
- Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic with progression after treatment with available standard therapies.
- Documentation of KRAS/NRAS/HRAS mutation determined by validated local testing of tumor tissue or circulating free DNA (cfDNA) in a certified laboratory
- Have consented to provide archival tumor tissue collected within 3 years or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
- Have adequate organ functions
- Have discontinued all previous treatments for cancer with resolution of any adverse events (AEs) to ≤ Grade 1
Exclusion Criteria:
- Are currently enrolled in a clinical study involving an investigational product or any other type of medical research
- Have tumors previously tested positive for Class I BRAF mutations i.e. V600X
- Prior treatment with a pan-RAS(ON) inhibitor
- Gastrointestinal conditions that may interfere with drug absorption
- Have a serious concomitant systemic disorder
- Have a serious pre-existing medical condition(s)
- Prior or second concurrent primary malignancies
- Moderate or severe cardiovascular disease
- Have symptomatic central nervous system (CNS) malignancy or metastasis
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: ASKC189 oral capsule
|
ASKC189 for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
Časové okno: Up to 21 days following first dose
|
DLT is short for Dose Limiting Toxicity, dose-limiting describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. |
Up to 21 days following first dose
|
|
Number of participants with adverse events and serious adverse events as assessed by CTCAE v6.0
Časové okno: Up to 30 days following last dose
|
AE refers to any untoward medical occurrence or deterioration of existing medical event after the investigational treatment, whether or not considered related to the study treatment. |
Up to 30 days following last dose
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Characterization of the PK profile of ASKC189
Časové okno: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
|
AUC(inf) after single dose and AUC (0-τ) after single and multiple doses Maximum blood concentration (Cmax) |
At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
|
|
Characterization of the PK profile of ASKC189: blood concentration characteristics
Časové okno: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
|
Time to maximum blood concentration (Tmax) |
At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
|
|
Characterization of the PK profile of ASKC189: steady state characterization
Časové okno: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
|
Accumulation ratio (AR) at steady-state |
At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
|
|
Characterization of the PK profile of ASKC189: drug level characterization in blood
Časové okno: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
|
Apparent clearance (CL/F) after single and multiple doses |
At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
|
|
Characterization of the PK profile of ASKC189
Časové okno: At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
|
ASKC189 apparent terminal half-life (t1/2) |
At time points pre-dose, 1, 2, 4, 6, 8, 24 hours post dose
|
|
Objective response rate (ORR)
Časové okno: Up to approximately 3 years
|
ORR is defined as the proportion of subjects with confirmed CR or confirmed PR (based on RECIST Version 1.1). |
Up to approximately 3 years
|
|
Disease control rate (DCR)
Časové okno: Up to approximately 3 years
|
DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST Version 1.1). |
Up to approximately 3 years
|
|
Duration of Response (DoR)
Časové okno: Up to approximately 3 years
|
DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first. |
Up to approximately 3 years
|
|
Progression-free survival (PFS)
Časové okno: Up to approximately 3 years
|
PFS is defined as the time from the start of treatment until the first documentation of disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first. |
Up to approximately 3 years
|
|
Overall survival (OS)
Časové okno: Up to approximately 3 years
|
OS defined as the time from the first dose to death from any cause. |
Up to approximately 3 years
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The identification of potential predictive biomarkers associated with response or resistance to ASKC189
Časové okno: Up to approximately 3 years
|
Correlation of clinical outcomes with biomarkers to specific RAS mutation subtypes, and co-mutations in tumor tissue at baseline and progressive disease. |
Up to approximately 3 years
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- ASKC189-102
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .