First in Human Study of AZD9592 in Solid Tumors

Launched by ASTRAZENECA · Dec 2, 2022

Keywords

ClinConnect Summary

This clinical trial, called the First in Human Study of AZD9592, is exploring a new treatment for patients with advanced solid tumors, including types of lung, head and neck, and colorectal cancers. The study is designed to evaluate how safe and effective this new drug, AZD9592, is when given alone or with other cancer treatments. Researchers will monitor how the drug is processed in the body and its effects on tumors. The trial is currently recruiting participants who are at least 18 years old, have a certain level of health (ECOG Performance Status of 0-1), and have measurable cancer that fits specific criteria.

Eligible participants can expect to receive the new treatment and undergo various tests to help researchers understand its impact. The trial is open to all genders, and participants will be carefully screened to ensure they do not have certain health issues that could complicate the study. It’s important to know that this trial is in the early stages, meaning it’s the first time this drug is being tested in humans, and there may be both benefits and risks involved.

Gender

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Eligibility 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; 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.
• 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