BridgeMD
A trial to learn how well AZD0901 works and how safe it is compared to standard cancer treatments in adults with advanced and metastatic gastric or gastroesophageal junction cancers with high levels of a protein called CLDN18.2
EU CTIS ID: 2023-508276-11-00
What this study is testing
To demonstrate the superiority of AZD0901 relative to Investigator’s choice of therapy by assessment of PFS in all randomized participants. To demonstrate the superiority of AZD0901 relative to Investigator’s choice of therapy by assessment of OS for 3L+ participants
- Therapeutic confirmatory (Phase III)
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 at least 18 years or the legal age of consent in the jurisdiction
- Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus (distal third of the esophagus) and the following requirement a) With positive CLDN 18.2 expression determined by central lab. For participants who have received prior CLDN18.2 targeting therapies a new biopsy upon progression must be provided for testing to determine CLDN18.2 expression.
- Disease progression on or after at least one prior line of treatment (LoT), which included a fluoropyrimidine and a platinum, for advanced or metastatic disease.
- Must have at least one measurable or evaluable lesion assessed by the Investigator based on RECIST 1.1
- ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
- Predicted life expectancy of ≥ 12 weeks
You likely can't join if
- Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH + (Cases with HER2: CEP17 ratio ≥ 2 or an average HER2 copy number ≥ 6.0 signals/cell are considered positive by ISH). Participants must undergo local (or have had) HER2 testing by IHC/ISH, and the most recent result of HER2 status will be used to determine the eligibility.
- Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.
- CNS metastases or CNS pathology including: epilepsy, seizures, or aphasia within 3 months prior to consent, severe brain injury, dementia, Parkinson’s disease, neurodegenerative diseases, cerebellar disease, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases. The following are exceptions to this criterion: (a) Participants with history of seizures are permitted if no active seizures in last 5 years. (b) Participants with brain metastases treated, asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to randomization. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrolment.
- Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations).
- Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss).
- Prior exposure to any ADC with MMAE payload or any CLDN18.2 targeting treatment other than naked monoclonal antibody (eg, CLDN18.2 targeting CAR-T cell therapy, multi-specific antibody including targeting CLDN18.2, etc).
See the full eligibility criteria
Who can join
- Participant must be at least 18 years or the legal age of consent in the jurisdiction
- Histologically confirmed unresectable, locally advanced or metastatic adenocarcinoma of gastric, GEJ, or distal esophagus (distal third of the esophagus) and the following requirement a) With positive CLDN 18.2 expression determined by central lab. For participants who have received prior CLDN18.2 targeting therapies a new biopsy upon progression must be provided for testing to determine CLDN18.2 expression.
- Disease progression on or after at least one prior line of treatment (LoT), which included a fluoropyrimidine and a platinum, for advanced or metastatic disease.
- Must have at least one measurable or evaluable lesion assessed by the Investigator based on RECIST 1.1
- ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
- Predicted life expectancy of ≥ 12 weeks
- Adequate organ and bone marrow function as show in table in full CSP
- Body weight of ≥ 35 kg
- Sex and contraceptive requirements
What rules you out
- Participants with known HER2 positive status as defined as IHC 3+ or IHC 2+/ISH + (Cases with HER2: CEP17 ratio ≥ 2 or an average HER2 copy number ≥ 6.0 signals/cell are considered positive by ISH). Participants must undergo local (or have had) HER2 testing by IHC/ISH, and the most recent result of HER2 status will be used to determine the eligibility.
- Participant has significant or unstable gastric bleeding and/or untreated gastric ulcers.
- CNS metastases or CNS pathology including: epilepsy, seizures, or aphasia within 3 months prior to consent, severe brain injury, dementia, Parkinson’s disease, neurodegenerative diseases, cerebellar disease, severe uncontrolled mental illness, psychosis, CNS involvement of autoimmune diseases. The following are exceptions to this criterion: (a) Participants with history of seizures are permitted if no active seizures in last 5 years. (b) Participants with brain metastases treated, asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to randomization. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrolment.
- Participant has known clinically significant corneal disease (eg, active keratitis or corneal ulcerations).
- Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss).
- Prior exposure to any ADC with MMAE payload or any CLDN18.2 targeting treatment other than naked monoclonal antibody (eg, CLDN18.2 targeting CAR-T cell therapy, multi-specific antibody including targeting CLDN18.2, etc).
- History of thromboembolic events
- As judged by the Investigator, any evidence of diseases which in the Investigator’s opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Taiwan
- Brazil
- Canada
- Turkey
- United Kingdom
- China
- India
- United States
- Korea, Republic of
- Hong Kong
- Thailand
- Vietnam
- Japan
- Switzerland
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 Taiwan; Brazil; Canada; Turkey; United Kingdom; China and 8 more location(s). 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.