First in Human Study of AZD9592 in Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2024-09-13
• Target enrollment: 0
• Participant gender: All

Summary

This is a first-in-human (FIH) Phase I, multi-center, open-label, study of AZD9592, in patients with advanced solid tumors. The study consists of several study modules, each evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), pharmacodynamics, anti-tumor activity, and immunogenicity of AZD9592, as monotherapy or in combination with anti-cancer agents.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Osimertinib

Criteria

Key Inclusion Criteria:

• Age ≥ 18 years

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

• Life expectancy ≥ 12 weeks

• 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; recurrant or metastatic HNSCC of the oral cavity Additional Inclusion Criteria for Module 2

• Histologically or cytologically confirmed metastatic NSCLC EGFRmut.

Key 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