Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This study is the first time a new medicine called AZD9592 is being tested in people. It is an early-phase (Phase I), open-label study, meaning both patients and doctors know which treatment is being given.
The study will take place at several hospitals and will include people with advanced solid tumours.
The study has different parts. Each part will look at how safe AZD9592 is, how well patients can tolerate it, how the drug moves through the body, and how the body reponds to it.
Researchers will also look for early signs that AZD9592 may help shrink or control tumours. AZD9592 will be tested both on its own and together with other cancer treatments. These other treatments will include Osimertinib (in Module 2), and 5-FU, Bevacizumab, Leucovorin (in Module 3).
Conditions
This trial is treating people with advanced solid cancers, including metastatic non-small cell lung cancer with EGFR mutation, head and neck squamous cell carcinoma, or colorectal cancer.
Eligibility
Inclusion
- 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.
Exclusion
- 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
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body, but it is not possible to perform surgery to remove it (unresectable).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov, EU Clinical Trials Register *. View further details about this trial on the registry via the links below:
Trial sponsor
AstraZeneca
Scientific Title
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
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