Clinical trial for Gastric Cancer
Official title AZD0901 in Participants With Advanced Solid Tumours Expressing Claudin18.2
ClinicalTrials.gov ID: NCT06219941
What this study is testing
What is AZD0901?
AZD0901 is an investigational antibody-drug conjugate being studied as a potential treatment for gastric cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study looks at how safe and well tolerated AZD0901 is, whether it works, how it moves through the body, and if it triggers immune reactions, both alone and with other cancer drugs.
- Who it's for
- Adults with locally advanced or metastatic gastric, gastroesophageal junction, biliary tract, or pancreatic cancers that show CLDN18.2 expression.
- What's involved
- Participants receive AZD0901, either by itself or together with other cancer treatments, and will have regular clinic visits and medical tests to monitor safety and effectiveness.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.
- Participants who are CLDN18.2 positive.
- Must have at least one measurable lesion according to RECIST v1.1.
- ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.
- Predicted life expectancy of ≥ 12 weeks.
You likely can't join if
- Unstable or active peptic ulcer disease or digestive tract bleeding including but not limited to clinically significant bleeding in the setting of...
- Participants with clinically significant ascites that require drainage.
- A history of drug-induced non-infectious ILD/pneumonitis.
- Central nervous system metastases or CNS pathology.
- Peripheral neuropathy, sensory, or motor ≥ Grade 2 at screening.
- History of another primary malignancy.
See the full eligibility criteria
- Participant must be ≥ 18 years or the legal age of consent at the time of signing the ICF.
- Participants who are CLDN18.2 positive.
- Must have at least one measurable lesion according to RECIST v1.1.
- ECOG performance status of 0 to 1 with no deterioration over the previous 2 weeks prior first day of dosing.
- Predicted life expectancy of ≥ 12 weeks.
- Adequate organ and bone marrow function as defined by protocol.
- Body weight \> 35 kg.
- Participants are willing to comply with contraception requirements. Sub study 1 Specific
- Histologically confirmed adenocarcinoma of the stomach or gastroesophageal junction.
- Advanced or metastatic GC/GEJC.
- Maximum 2 prior lines of systemic treatment for unresectable or metastatic disease. Sub study 2 Specific
- Participants diagnosed with histologically confirmed metastatic or advanced PDAC.
- Availability of an archival sample or a fresh tumour biopsy taken at screening.
- No prior treatments for unresectable or metastatic disease. Prior neoadjuvant/adjuvant chemotherapy is permitted as long as participants progressed ≥ 6 months (183 days) from the last dose.
- Documented radiographic or clinical disease progression on or after at least one prior regimen and maximum 2 prior lines of systemic treatment for unresectable or metastatic disease. Master
- 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.
- A history of drug-induced non-infectious ILD/pneumonitis.
- Central nervous system metastases or CNS pathology.
- Peripheral neuropathy, sensory, or motor ≥ Grade 2 at screening.
- History of another primary malignancy.
- Prior exposure to any MMAE-based ADC.
- Participants with HER2-positive (3+ by IHC, or 2+ by IHC, and positive by ISH) or indeterminate GC/GEJC unless they have failed/not tolerated/or are not eligible for standard anti-HER2 therapy, where available.
- Any factors that increase the risk of QTc prolongation or risk of arrhythmic events.
- Known DPD enzyme deficiency based on local testing where testing is SoC.
- Use of strong inhibitor or inducer of UGT1A1.
- Use of strong inhibitors or inducers of CYP3A4.
- Known homozygous for the UGT1A1\ 28 allele based on local testing where testing is SoC. Sub study 3 Specific Exclusion criteria
- Clinically significant biliary obstruction that has not resolved before enrollment.
The study team makes the final eligibility decision.
Where it is enrolling
- Orange, California, United States
- Palo Alto, California, United States
- Santa Rosa, California, United States
- Louisville, Kentucky, United States
- Commack, New York, United States
- Providence, Rhode Island, United States
- Houston, Texas, United States
- Melbourne, Australia
- Murdoch, Australia
- Randwick, Australia
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Sherbrooke, Quebec, Canada
- Tbilisi, Georgia
- Chūōku, Japan
- Kashiwa, Japan
- Kitaadachi-gun, Japan
- Kōtoku, Japan
- Nagoya, Japan
- Osakasayama-shi, Japan
+ 18 more site(s).
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, but 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Orange, California, United States; Palo Alto, California, United States; Santa Rosa, California, United States; Louisville, Kentucky, United States; Commack, New York, United States; Providence, Rhode Island, United States and 32 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.