TAS0612 for Advanced or Metastatic Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Taiho Oncology, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called TAS0612 to see if it is safe for people with advanced or metastatic solid tumor cancer.

Eligibility Criteria

This trial is for adults with advanced or metastatic solid tumors, excluding brain tumors. Participants must have good organ function and a performance status of 0 or 1 on the ECOG scale. Specific cohorts include those with certain genetic mutations like PTEN loss, KRAS G12D/C mutation, NF1 mutation in HER2 negative breast cancer, and HR+/HER2 negative breast cancer resistant to standard treatments.

Inclusion Criteria

I am fully active or restricted in physically strenuous activity but can do light work.

My organs are functioning well.

My cancer is advanced or has spread but does not originate from the brain.

+7 more

Exclusion Criteria

I cannot swallow or digest pills.

I have a brain tumor that originated in my brain.

My diabetes is not well-managed.

+6 more

Participant Groups

The study is testing TAS0612's safety for patients with various types of advanced solid tumors. It includes different phases: dose escalation to find the safe dosage levels and dose expansion to test effectiveness in specific patient groups defined by genetic characteristics of their cancers.

2Treatment groups

Experimental Treatment

Group I: TAS0612 ExpansionExperimental Treatment1 Intervention

TAS0612 administered orally

Group II: TAS0612 EscalationExperimental Treatment1 Intervention

TAS0612 administered orally