Advanced Solid Tumors, Lymphoma
Conditions
Brief summary
The purpose of this study is to identify subjects with advanced solid tumors or lymphoma in which the methylthioadenosine phosphorylase (MTAP) protein has been lost.
Detailed description
Study AG270-PS-001 is a pre-screening study to identify subjects with advanced solid tumors or lymphoma in which the MTAP protein has been lost. Subjects whose tumor tissue has lost the MTAP protein may be considered for future enrollment into a Phase 1 clinical study of an experimental drug, AG-270, that is designed to inhibit the growth of tumors lacking this protein. Identification of the loss of MTAP will rely solely on the evaluation of archival tumor tissue samples by IHC. This study is therefore non-interventional
Interventions
None listed
Sponsors
Agios Pharmaceuticals, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be ≥18 years of age. 2. Have a histologically confirmed diagnosis of an advanced solid tumor (other than a primary CNS malignancy) or lymphoma. 3. Have archival tumor tissue that can be provided for assessment of MTAP deletion status. 4. Have given written informed consent to participate in this study.
Exclusion criteria
1. Have a primary CNS malignancy (eg, GBM). 2. Have a medical or psychological condition deemed by the Investigator likely to interfere with the subject's ability to give informed consent or participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of MTAP status in tumors | From initiation of the Pre-Screen study until the Phase 1 study of AG-270 is activated at each study site, up to 9 months | Number of tumor tissue samples found to have or not have MTAP deletion, as assessed by IHC |
Countries
Spain, United States
Outcome results
None listed