A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taiho Oncology, Inc.

Criteria

Inclusion Criteria:

• Dose Escalation: have evidence of a solid tumor that is locally advanced and/or metastatic (excluding primary brain tumor)

• Dose Expansion: have evidence of a solid tumor as outlined below that is locally advanced and/or metastatic (excluding primary brain tumor)

• Cohort A: Human epidermal growth factor negative (HER2 negative) Breast Cancer with an NF1 mutation

• Cohort B: Hormone receptor positive (HR+)/HER2 negative breast cancer after progression on endocrine therapy and a CDK4/6 inhibitor

• Cohort C: PTEN loss or mutations

• Cohort D: KRAS G12C mutation

• Cohort E: KRAS G12D mutation

• Have adequate organ function

• Amenable to biopsy

• Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

Exclusion Criteria:

• Participating in medical research not compatible with this study

• Have not discontinued or recovered from previous treatments for cancer

• Have a significant cardiac condition

• Have untreated brain metastases

• Have a primary brain tumor

• Have a serious concomitant disorder

• Unable to swallow or digest pills

• Poorly controlled diabetes

• Concomitant medications or substances that are strong inhibitors/inducers of CYP3A.Study