BridgeMD
A trial to learn how safe AZD4360 is, how well it works, and how it moves throughout the body over time in adults with advanced solid tumors
EU CTIS ID: 2024-518281-27-00
What this study is testing
To investigate the safety and tolerability, and to determine the Maximum Tolerated Dose and/or a Recommended Phase 2 Dose of AZD4360 in previously treated participants with advanced solid tumours 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
- Participant must be ≥ 18 at the time of signing the ICF.
- Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
- Minimum life expectancy of 12 weeks in the opinion of the Investigator.
- Adequate organ and marrow function, as defined by protocol.
- Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.
- Histologically confirmed advanced or metastatic Pancreatic ductal adenocarcinoma (PDAC), Gastric or Gastroesophageal junction cancer (G/GEJC), and Biliary tract cancer (BTC) with documented positive CLDN18.2 expression.
You likely can't join if
- Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ hybridisation) or indeterminate G/GEJC participants.
- Known HIV infection that is not well controlled.
- Active tuberculosis infection.
- Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
- Participants with clinically significant ascites that require drainage.
- Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.
See the full eligibility criteria
- Participant must be ≥ 18 at the time of signing the ICF.
- Eastern cooperative oncology group performance status of 0-1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
- Minimum life expectancy of 12 weeks in the opinion of the Investigator.
- Adequate organ and marrow function, as defined by protocol.
- Contraceptive use by men or women should be consistent with local regulations, as defined by protocol.
- Histologically confirmed advanced or metastatic Pancreatic ductal adenocarcinoma (PDAC), Gastric or Gastroesophageal junction cancer (G/GEJC), and Biliary tract cancer (BTC) with documented positive CLDN18.2 expression.
- Participants must have received at least one prior line of systemic therapy in the advanced/metastatic disease.
- At least one measurable lesion according to RECISTv1.1.
- Human Epidermal Growth Factor Receptor 2 (HER2) positive (3+ by IHC or 2+ by IHC and positive by in situ hybridisation) or indeterminate G/GEJC participants.
- Known HIV infection that is not well controlled.
- Active tuberculosis infection.
- Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of prior CLDN18.2 directed therapy.
- Participants with clinically significant ascites that require drainage.
- Central nervous system (CNS) metastases or CNS pathology, as defined by protocol.
- With spinal cord compression or with high risk of paralysis.
- History of non-infectious interstitial lung disease/pneumonitis.
- Participant has cardiac abnormalities, as defined by protocol.
- History of another primary malignancy within 2 years prior to screening.
- Known serologic status reflecting active hepatitis B or hepatitis C.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
- China
- United Kingdom
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, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States; China; United Kingdom. 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.