Study Name
Study Title
Start Date
Enrollment Status
Sponsor
Study Type
Location
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Main Inclusion
- Age ≥ 18 years
- Relapsed/metastatic solid tumors treated with prior adequate standard of care therapy for tumor type and stage of disease or where in the opinion of the Investigator, a clinical trial is the best option for the next treatment based on response and/or tolerability to prior therapy.
- Measurable disease per RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
- Life expectancy ≥ 12 weeks
- Adequate organ and marrow function as defined in the protocol
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Exclusion Criteria
- Treatment with any of the following:
- Nitrosourea or mitomycin C within 6 weeks prior to the first dose of study treatment
- Any investigational agents or study drugs from a previous clinical study within 5 half-lives or 28 days (whichever is shorter) prior to the first dose of study treatment
- Any other anticancer treatment within the following time periods prior to the first dose of study intervention:
- Cytotoxic treatment: 21 days
- Non-cytotoxic drugs: 21 days or 5 half-lives (whichever is shorter)
- Biological products including immuno-oncology agents: 28 days
- Spinal cord compression or a history of leptomeningeal carcinomatosis.
- Brain metastases unless treated, 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.
- Active infection including tuberculosis and HBV, HCV or HIV
- 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.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
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Treatment Information
This is a first time in human (FTiH) Phase I/IIa, open-label, multi-center study of AZD8205 administered to participants with advanced or metastatic solid malignancies. The study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of AZD8205.
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Costs & Stipend Details
The participant will receive a stipend for each completed visit.
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General Information
This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours.
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