A Phase I, Multicenter, Open-label, First-in-Human, Dose Escalation and Expansion Study of AZD9592 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumors

Recruiting

• Conditions: Advanced Solid Tumours, Carcinoma Non-small Cell Lung, Head and Neck Neoplasms

• Registration Number: jRCT2031230002
• Lead Sponsor: Astrazeneca K.K

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-02
• Last Update Posted: 2023-11-22

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 417

Inclusion Criteria

• Age 18 years or more

• Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1

• Life expectancy 12 weeks or more

• Measurable disease per RECIST v1.1

• Adequate organ and marrow function as defined in the protocol

Additional Inclusion Criteria for Module 1:

• Histologically or cytologically confirmed metastatic or locally advanced EGFRmut., NSCLC; metastatic EGFRwt. NSCLC; recurrent or metastatic HNSCC of the oral cavity; metastatic CRC.

Additional Inclusion Criteria for Module 2:

• Histologically or cytologically confirmed metastatic NSCLC EGFRmut.

Additional Inclusion Criteria for Module 3:

• Histologically or cytologically confirmed metastatic CRC.

Exclusion Criteria

• History of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.

• Spinal cord compression or a history of leptomeningeal carcinomatosis.

• Active infection including tuberculosis and HBV, HCV or HIV

• Brain metastases unless treated (prior treatment required only for Module 1), asymptomatic, stable, and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment.

• Participants with cardiac comorbidities as defined in the study protocol

Study & Design

• Study Type: Interventional
• Study Design: single assignment

Primary Outcome Measures

Name	Time	Method
Incidence of Serious Adverse Events (SAEs)	From time of Informed Consent to 30 days post last dose of AZD9592	Number of patients with serious adverse events by system organ class and preferred term
Incidence of dose-limiting toxicities (DLT) as defined in the protocol	From time of first dose of AZD9592 to end of DLT period (approximately 21 days)	Number of patients with at least 1 dose-limiting toxicity (DLT), which is any toxicity defined as a DLT in the Clinical Study Protocol
Incidence of Adverse Events (AEs)	From time of Informed Consent to 30 days post last dose of AZD9592	Number of patients with adverse events by system organ class and preferred term
Incidence of baseline laboratory finding, ECG and vital signs changes	From time of Informed Consent to 30 days post last dose of AZD9592	measured by laboratory and vital sign variables over time including change from baseline
Proportion of patients with radiological response (ORR)	From date of first dose of AZD9592 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)	Assessed by overall response rate (ORR) defined as the proportion of patients who have a confirmed complete or partial radiological response by the Investigator according to RECIST v1.1 (for patients in the dose expansion cohorts, only)