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CAM-H2 for Breast or Gastric Cancer
Study Summary
This trial is testing a new cancer treatment to see if it is safe and effective. The study will last up to 18 months and will test the treatment on patients with HER2-positive breast, gastric, or GEJ cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have issues with controlling your urine.You have brain metastases that are causing symptoms. However, if you have brain metastases that are not causing any symptoms and have been treated or untreated, you can still participate.You have severe heart failure symptoms, like difficulty breathing or chest pain, that limit your daily activities.You are expected to live for at least 6 more months.You have a condition affecting your digestive system that makes it difficult for you to take medicine by mouth, or you require IV feeding. You may also be excluded if you have had surgery that affects how your body absorbs medicine, or if you have uncontrolled inflammation in your digestive system.You have a history of heart problems like unstable angina, heart failure, recent heart attack, severe heart rhythm issues, or other serious heart conditions.You have a serious infection that is not being properly treated or controlled.You have had other types of cancer in the past 3 years, except for certain types that have been treated successfully. These exceptions include cervical cancer, skin cancers like basal cell carcinoma or squamous cell carcinoma, and early-stage uterine cancer.You have received experimental cancer treatment within the last 4 weeks before starting CAM-H2.You have advanced breast cancer or stomach cancer that has not responded to standard treatments.If you have breast cancer, you should have tried at least two different treatments before. If you have gastric or GEJ cancer, you should have tried at least one treatment specifically targeting the HER2 protein.You have received radiation therapy for cancer in areas other than the brain within the past three weeks.
- Group 1: Dose Escalation and Expansion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many venues are presently running this research trial?
"The current clinical trial has 13 operational sites, situated in cities such as Glen Burnie, Stanford and Maywood. In order to minimize travel costs associated with the study, it's best for participants to select a centre nearest them if they decide to enrol."
What is the current sample size of this research project?
"This research requires 70 eligible individuals for participation. Subjects can join from two institutions, Advanced Molecular Imaging & Therapy in Glen Burnie and Stanford University Medical Center located in California."
Has recruitment for this study commenced?
"According to clinicaltrials.gov, this research is actively enrolling participants and has been since September 14th 2021. The study was most recently updated on July 6th 2022."
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