Avutometinib and Defactinib in Diffuse Gastric Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRyan H. Moy, MD, PhD
About this trial
The purpose of this study is to determine if the combination study treatment with avutometinib and defactinib will prolong life in participants, is effective in decreasing the size of the tumor(s), and if it is safe in subjects with diffuse-type stomach cancer.
Eligibility criteria
Qualifiers
Histologic or cytologic evidence of gastric/gastroesophageal junction carcinoma, classified as diffuse type, poorly cohesive, signet ring cell, or mixed type. Patients with known pathogenic CDH1 and/or RHOA mutations will be allowed regardless of histology.
Prior therapy with at least one line of therapy for unresectable/metastatic disease, which must include platinum and fluoropyrimidine.
ECOG performance status of 0 or 1
Age ≥ 18 years
Disqualifiers
Systemic anti-cancer therapy within 3 weeks of the first dose of study therapy, or within 5 half-lives of the previous drug, whichever is shorter.
Patients currently receiving any other investigational agent.
Subjects may not have had a history of malignancy other that esophagogastric cancer within two years prior to screening, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year overall survival >90%) such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer.
Major surgery within 4 weeks or palliative radiotherapy within 1 week of the first dose of study therapy.
Trial design
Treatments tested in this trial
- Avutometinib
- Defactinib
Treatment groups
27 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov