A Phase 1/2 Study of FOG-001 in Participants with Locally Advanced or Metastatic Solid Tumors
To see how safe and tolerable the study drug is when given alone and together with other anticancer drugs at different dose levels in patients; To determine the optimal dose of the study drug when given alone and together with other anticancer drugs that is effective but does not result in severe side effects; To evaluate the preliminary anti-tumor activity of the study drug when given alone and together with other anticancer drugs in people with advanced or metastatic cancer.
Why this Research Matters
FOG-001 is currently being developed to treat people with cancer. It is known that genetic mutations (changes in genetic material, for example, deoxyribonucleic acid [DNA]) in components of the WNT signaling pathway, part of the internal “wiring” of certain tumor cells, are very common in the development of human cancer, including colorectal cancer (CRC) and others. Mutations in the WNT pathway lead to the formation of cancer cells in the body which are often dependent on a critical factor called β-catenin. FOG-001 has been shown to work by directly inhibiting β-catenin in certain types of cancers in animal studies and subsequently slowing down the growth or shrinking these tumors. The purpose is to find the safest and most active dose of the study drug to give to the participants, when given alone or in combination with other anticancer drugs.
Who can Participate
Inclusion: -Adult participants with a proven diagnosis of locally advanced or metastatic 1) solid tumor with documented WPAM (by local testing, with exception for certain tumor types specified in Appendix 10) who are unfit for or do not have available systemic therapy options; or 2) non-MSI-H or non-dMMR (by local testing) colorectal adenocarcinoma (irrespective of WPAM status) that have received at least one prior systemic therapy and either a) has progressed on or was nonresponsive to available therapies or b) is unfit for available therapies. Exclusion: -Known history of bone metastasis, unless otherwise specified. -Osteoporosis defined as a T-score of ≤-2.5 at the lumbar spine (L1 – L4), left (or right) femoral neck or left (or right) total hip as determined by DXA scan. For premenopausal females and males <50 years of age use Z scores and exclude if Z score ≤-2.5 at any site. Your doctor or study team will go over these requirements with you. More detailed information is available on ClinicalTrials.gov. You can click the NCT number link below to learn more about this study on ClinicalTrials.gov.
Study ID
Protocol Number: 25-2227
More information available at ClinicalTrials.gov: NCT05919264
Meet the Team
Principal Investigator