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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Phase 1
Kontakte und Standorte
Studienkontakt
- Name: Jiangsu Aosaikang Study Director
- Telefonnummer: +86 025 52169999
- E-Mail: ctr-contact@ask-pharm.com
Studienorte
-
-
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Beijing, China
- Peking University Cancer Hospital
-
Hauptermittler:
- Lin Shen, MD
-
Shanghai, China
- Shanghai East Hospital
-
Hauptermittler:
- Caicun Zhou, MD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: ASKC189 oral capsule
|
ASKC189 for every cycle of 21 days until disease progression or other criteria for treatment discontinuation will be met. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The incidence and case number of DLT (Dose Limiting Toxicity) during observation period
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Characterization of the PK profile of ASKC189
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Up to approximately 3 years
|
OS defined as the time from the first dose to death from any cause. |
Up to approximately 3 years
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
The identification of potential predictive biomarkers associated with response or resistance to ASKC189
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- ASKC189-102
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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