AZD0901 for Advanced Tumors
Phase 2
190
about 3.1 years
18+
7 sites in CA, KY, NY +2
What this study is about
This trial is testing AZD0901, a medication, in people with advanced solid tumors that express CLDN18.2. The goal is to see if AZD0901 is safe and effective when used alone or with other cancer treatments.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take 5-Fluorouracil
- 2.Take AZD0901
- 3.Take Gemcitabine
- +3 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You are randomly assigned, but you will know your treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
fluorouracil (Antimetabolite; mimics uracil to disrupt DNA/RNA in cancer cells), gemcitabine, irinotecan, Antidotes, Deterrents, and Toxicologic Agents (Enzyme Interactions)
injection (Injection)
Primary: Incidence of adverse events (AEs), serious AEs (SAEs). Changes from baseline in clinical laboratory parameters, vital signs, ECGs and physical examination. Rate of AEs leading to discontinuation of AZD0901, Occurrence of DLTs., Objective Response Rate (ORR).
Secondary: Clinical activity by baseline and/or on-treatment tissue-based biomarkers including, but not limited to, gene expression, mutation profiles, DNA damage, protein expression, immune response and/or mechanisms of resistance., Disease control rate (DCR), Duration of Response (DoR), Overall Survival (OS), Progression Free Survival (PFS), Serum PK parameters of AZD0901, total antibody (conjugated and unconjugated) and MMAE including but not limited to AUC, Cmax, tmax, clearance and half-life, as data allow.