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New treatment option for Gastric Cancer
Official title Sonesitatug Vedotin in Combination With Capecitabine With or Without Rilvegostomig in Participants With Advanced or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma Expressing Claudin18.2
ClinicalTrials.gov ID: NCT07431281
What this study is testing
What is Sonesitatug vedotin?
Sonesitatug vedotin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for gastric cancer.
Also referred to as AZD0901.
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 purpose of this study is to evaluate the efficacy and safety of sonesitatug vedotin in combination with capecitabine with or without rilvegostomig in first-line (1L) Claudin18.2 (CLDN18.2)-positive, human epidermal growth factor receptor 2 (HER2)-negative, gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.
- Phase 3: a large, late-stage study
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
- Capable of giving signed informed consent
- Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed...
- Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the...
- Positive CLDN18.2 expression, as determined prospectively by central IHC testing
- Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to determine cohort eligibility as...
You likely can't join if
- Known HER2-positive status
- Significant or unstable gastric bleeding and/or untreated gastric ulcers.
- Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed...
- CNS pathology
- Clinically significant pleural effusions or ascites and/or pleural effusions or ascites that require drainage, peritoneal shunt, or indwelling...
- Require parenteral nutrition support due to gastric or gastrointestinal obstruction.
See the full eligibility criteria
- Capable of giving signed informed consent
- Participant must be 18 years or the legal age of consent in the jurisdiction in which the study is taking place, at the time of signing the informed consent.
- Previously untreated histologically documented unresectable, locally advanced, or metastatic gastric, GEJ, or distal esophagus (distal third of the esophagus) adenocarcinoma
- Positive CLDN18.2 expression, as determined prospectively by central IHC testing
- Confirmed PD-L1 CPS status by central IHC testing and ICI eligibility per investigator judgement is required to determine cohort eligibility as described below:
- Cohort 1: PD-L1 positive as determined by central IHC testing and the participant is deemed ICI eligible per investigator judgement.
- Cohort 2: PD-L1 negative as determined by central IHC testing OR the participant is ICI ineligible
- ECOG performance status of 0 or 1 with no deterioration to \> 1 over the previous 2 weeks prior to baseline at screening and prior to randomisation.
- Minimum life expectancy of ≥ 12 weeks.
- At least one lesion (measurable and/or non-measurable) that can be accurately assessed by the investigator based on RECIST 1.1.
- Adequate organ and bone marrow function as specified in the protocol
- Body weight ≥ 35 kg.
- Sex and contraceptive requirements
- Known HER2-positive status
- Significant or unstable gastric bleeding and/or untreated gastric ulcers.
- Active or history of autoimmune or inflammatory disorders requiring systemic treatment with steroids or other immunosuppressive treatment or assessed by investigator as not appropriate to participate due to undue risk...
- CNS pathology
- Clinically significant pleural effusions or ascites and/or pleural effusions or ascites that require drainage, peritoneal shunt, or indwelling catheter/drain.
- Require parenteral nutrition support due to gastric or gastrointestinal obstruction.
- Peripheral neuropathy, sensory or motor, ≥ CTCAE Grade 2 at screening.
- Persistent toxicities caused by previous anticancer therapy excluding alopecia, not yet improved to Grade ≤ 1 or baseline.
- Cardiac abnormalities as outlined in the protocol
- Uncontrolled diabetes or diabetic neuropathy within 3 months prior to randomisation.
- Infectious disease including active hepatitis A infection; uncontrolled hepatitis B and/or chronic or active hepatitis B with HBV DNA ≥ 100 IU/mL; Known chronic, active, or uncontrolled hepatitis C; HIV infection that...
- Known partial or total DPD enzyme deficiency
The study team makes the final eligibility decision.
Where it's taking place
- Mobile, Alabama, United States
- Anchorage, Alaska, United States
- Phoenix, Arizona, United States
- Springdale, Arkansas, United States
- Duarte, California, United States
- Fullerton, California, United States
- La Jolla, California, United States
- Los Alamitos, California, United States
- Orange, California, United States
- Walnut Creek, California, United States
- Denver, Colorado, United States
- Lone Tree, Colorado, United States
- New Haven, Connecticut, United States
- Newark, Delaware, United States
- Washington D.C., District of Columbia, United States
- Fort Myers, Florida, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- St. Petersburg, Florida, United States
- West Palm Beach, Florida, United States
+ 227 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 - 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?
Study sites include Mobile, Alabama, United States; Anchorage, Alaska, United States; Phoenix, Arizona, United States; Springdale, Arkansas, United States; Duarte, California, United States; Fullerton, California, United States and 241 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.