Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Arvinas Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Part A:
Histological or cytological diagnosis of unresectable or metastatic solid tumor malignancy, AND
Must have evidence of KRAS G12D mutation in tumor tissue or blood (circulating tumor deoxyribonucleic acid \[ctDNA\]), AND
Must have received prior standard-of-care (SOC) therapy appropriate for their type and stage of disease and have no other available treatment options with curative intent, or, in the opinion of the investigator, would be unlikely to tolerate or derive clinically meaningful benefit from appropriate SOC therapy, AND
Must have at least 1 measurable lesion
Part B:
Histological or cytological diagnosis of unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) with KRAS G12D mutation status confirmed by local testing of tumor tissue using a validated molecular or next-generation sequencing (NGS) testing, AND
Must be willing to provide archival tumor tissue or willing to undergo pretreatment biopsy, AND
Must have received at least one prior standard of care systemic therapy for PDAC (systemic therapy received in the neoadjuvant or adjuvant setting is allowed), AND
Participants must have at least 1 measurable lesion
Part A / Part B:
Eastern Cooperative Oncology Group performance status of 0 or 1,
Participants with adequate organ function,
Participants must accept and follow pregnancy prevention guidance.
You may not be if
Part A / Part B:
Active brain metastases
Carcinomatous meningitis
Uncontrolled hypertension despite optimal medical therapy
Prior treatment with a KRAS G12D or a KRAS G12C targeting therapy (pan-KRAS inhibitor/degrader included)
Participants with an inability to comply with listed prohibited treatments
Systemic anticancer therapy within 2 weeks or 5 half-lives (whichever is shorter) or radiation therapy (excluding palliative radiation) within 2 weeks prior to the study intervention treatment. If the last immediate anticancer treatment contained an antibody-based agent(s), then an interval of 28 days or 5 half-lives (whichever is shorter) of the agent(s) is required prior to receiving the study intervention treatment.
Standard 12-lead electrocardiogram that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
Clareo Health | A Study to Evaluate ARV-806 in Adults With Advanced Cancer That Has the KRAS G12D Mutation
