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.
- HER2-positive Breast, Gastric, Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care Treatment
3 Primary · 6 Secondary · Reporting Duration: 18 months
Awards & Highlights
1 Treatment Group
Dose Escalation and Expansion
1 of 1
70 Total Participants · 1 Treatment Group
Primary Treatment: CAM-H2 · No Placebo Group · Phase 1 & 2
Who is running the clinical trial?
Age 18+ · All Participants · 1 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- D’Huyvetter, Matthias, Jens De Vos, Vicky Caveliers, Ilse Vaneycken, Johannes Heemskerk, Francois P. Duhoux, Christel Fontaine, et al.. 2020. “Phase I Trial of 131i-gmib-anti-her2-vhh1, a New Promising Candidate for Her2-targeted Radionuclide Therapy in Breast Cancer Patients”. Journal of Nuclear Medicine. Society of Nuclear Medicine. doi:10.2967/jnumed.120.255679.
- D'Huyvetter M, Vos J, Caveliers V, Vaneycken I, Heemskerk J, Duhoux FP, Fontaine C, Vanhoeij M, Windhorst AD, Aa FV, Hendrikse NH, Eersels JLE, Everaert H, Gykiere P, Devoogdt N, Raes G, Lahoutte T, Keyaerts M. Phase I Trial of 131I-GMIB-Anti-HER2-VHH1, a New Promising Candidate for HER2-Targeted Radionuclide Therapy in Breast Cancer Patients. J Nucl Med. 2021 Aug 1;62(8):1097-1105. doi: 10.2967/jnumed.120.255679. Epub 2020 Dec 4.
- 2021. "A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04467515.
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor