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

A Phase 1 Study of TAS0612 in Patients With Locally Advanced or Metastatic Solid Tumors

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

Inclusion Criteria:

Dose Escalation:

Have histologically confirmed, locally advanced, and unresectable cancer, or metastatic cancer and have progressed on or were intolerant to standard treatments or refused standard of care (SOC).

Dose Expansion:

Have documented histologically or cytologically confirmed adenocarcinoma of the prostate with documented PTEN loss or loss of function mutation, who have metastatic castration-resistant disease and have:

• Disease progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3)/modified RECIST 1.1 after the most recent regimen.
• Received androgen receptor directed therapy previously with or without chemotherapy consisting of no more than 2 prior taxane-based regimens.
• Been receiving androgen deprivation therapy with serum testosterone <50 ng/dL (<2.0 nM). Note: previously documented PTEN loss or loss of function mutation from archived tissue sample testing or cfDNA sample testing is acceptable if done in a CLIA certified lab or a locally certified lab.

Have an ECOG score of 0 or 1 Dose Escalation (Part 1): Have no measurable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Dose Expansion (Part 2): Have measurable or no measurable disease per PCWG3/modified RECIST 1.1

• No more than 30 patients with no measurable disease will be enrolled in Dose Expansion (Part 2).

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