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A Phase I/II Study of AZD5863 in Adult Participants with Advanced or Metastatic Solid Tumors
EU CTIS ID: 2023-504139-42-00
What this study is testing
Dose Escalation (1) To investigate the safety and tolerability, characterise DLTs and determine MTD and/or RP2D(s) of AZD5863 as a monotherapy or in combination in participants with advanced or metastatic solid tumors with CLDN18.2 expression Dose Expansion (1) To investigate the safety and tolerability of AZD5863 monotherapy or in combination in participants with advanced or metastatic solid tumors with CLDN18.2 expression (2) To evaluate the preliminary antitumour activity of AZD5863 monotherapy or in combination in participants with advanced or metastatic solid tumors with CLDN18.2 expression
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 at the time of signing the informed consent
- Histologically confirmed diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction, esophagus, or pancreas
- Must have at least one measurable lesion according to RECIST v1.1
- Must show positive CLDN18.2 expression in tumor cells as determined by central IHC
- Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening
- Predicted life expectancy of ≥ 12 weeks
You likely can't join if
- Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for those defined by the protocol
- Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS)
- Participant experienced unacceptable CRS or ICANS following prior TCE or CAR-T cell therapy
- Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment
- CNS metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent
- Infectious disease including active HIV, active hepatitis B/C, uncontrolled infection with EBV, uncontrolled active systemic fungal, bacterial or other infection
See the full eligibility criteria
- Age ≥ 18 at the time of signing the informed consent
- Histologically confirmed diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction, esophagus, or pancreas
- Must have at least one measurable lesion according to RECIST v1.1
- Must show positive CLDN18.2 expression in tumor cells as determined by central IHC
- Eastern Cooperative Oncology Group Performance status (ECOG PS): 0-1 at screening
- Predicted life expectancy of ≥ 12 weeks
- Adequate organ and bone marrow function measured within 28 days prior to first dose as defined by the protocol
- Contraceptive use by men or women should be consistent with local regulations, as defined by the protocol
- Must have received at least one prior line of systemic therapy in the advanced/metastatic setting
- Unresolved toxicity from prior anticancer therapy of Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 2 except for those defined by the protocol
- Previous history of hemophagocytic lymphohistiocytosis (HLH) / macrophage activation syndrome (MAS)
- Participant experienced unacceptable CRS or ICANS following prior TCE or CAR-T cell therapy
- Active or prior documented autoimmune or inflammatory disorders within 3 years of start of treatment
- CNS metastases or CNS pathology, as defined by the protocol, within 3 months prior to consent
- Infectious disease including active HIV, active hepatitis B/C, uncontrolled infection with EBV, uncontrolled active systemic fungal, bacterial or other infection
- Cardiac conditions as defined by the protocol
- History of thromboembolic event within the past 3 months prior to the scheduled first dose of study intervention
- Participant requires chronic immunosuppressive therapy
- Participants on anticoagulation therapy with long-acting anticoagulants or other class of anticoagulants at therapeutic doses
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- China
- Taiwan
- Japan
- Korea, Republic of
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; China; Taiwan; Japan; Korea, Republic of. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.