Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–100
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Participant has provided informed consent/assent before initiation of any study specific activities/procedures.
Age ≥ 18 years.
Evidence of homozygous loss of cyclin dependent kinase inhibitor 2A (CDKN2A) (null) (Parts 1a, 1j, 1k, and 2a only) and/or methylthioadenosine phosphorylase (MTAP) (null) in the tumor tissue or blood (Parts 1a to 1k, Parts 2a and 2b) or lost MTAP expression in the tumor tissue (Parts 1a to 1k, Parts 2a and 2b).
Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation.
Able to swallow and retain orally (PO) administered study treatment and willing to record daily adherence to investigational product.
Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Note: except participants enrolling to Part 1m.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Adequate hematopoietic function per local laboratory
Adequate renal function per local laboratory
Adequate glucose control per local laboratory (Part 1 only)
Adequate liver function per local laboratory
Adequate coagulation parameters
Adequate pulmonary function
Adequate cardiac function
Minimum life expectancy of 12 weeks as per investigator judgement.
Archived tumor tissue (formalin-fixed, paraffin-embedded \[FFPE\] sample collected within 5 years) or an archival block must be available.
For Part 1f (MTAP-null or lost MTAP expression HNSCC): Must be willing to undergo tumor biopsy.
For Part 1a: Must be willing to undergo tumor biopsy, before start of treatment (archival sample acceptable if obtained with 6 months of enrollment and subject has not received any other treatment since sample was obtained) and while on treatment.
For DSPS study (Part 1j): Must be willing to participate in DSPS substudy (US sites only).
Subject able and willing to eat a standardized high-fat, high-caloric meal
Subject able and willing to fast for ≥ 6 hours
\- Disease measurable as defined per Modified Response Assessment in Neuro-Oncology Criteria 2.0 (mRANO 2.0)
You may not be if
Spinal cord compression or untreated brain metastases or leptomeningeal disease.
History of other malignancy within the past 2 years
Any evidence of current interstitial lung disease
Active infection
Evidence of active severe acute respiratory syndrome coronavirus 2 (SARS-COV2) infection.
History of bowel obstruction, abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
History of solid organ transplant.
Diagnosis of Congenital Short QT Syndrome.
Major surgery
Anti-tumor therapy within 28 days of study day 1.
Prior treatment with an methionine adenosyltransferase 2α (MAT2A) inhibitor or a protein arginine methyltransferase 5 (PRMT5) inhibitor.
Prior treatment with docetaxel (Part 2 only)
Prior irradiation to 25% of the bone marrow.
Therapeutic or palliative radiation therapy within 2 weeks of study day 1.
Live vaccine therapy within 4 weeks before study drug administration.
Use of therapeutic anti-coagulation for treatment of active thromboembolic events.
Use of prescription medications that are known strong inducers of cytochrome P450 3A4 (CYP3A4) within 14 days or 5 half-lives (whichever is longer) before study day 1
Unresolved toxicity from prior anti-cancer therapy
Currently receiving treatment in another investigational device or drug study.
Known positive test for Human Immunodeficiency Virus (HIV).
Positive hepatitis B surface antigen
positive hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR)
Female participants of childbearing potential unwilling to use protocol specified method of contraception
Clareo Health | A Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101)
