A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer
Stopped early · Phase 1
Conditions studied: Advanced or Metastatic Solid Tumors
In brief
The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.
Key facts
- Study ID
- NCT04586270
- Run by
- Taiho Oncology, Inc.
- People needed
- 47
- Starts
- 2020-10-15
- Expected to finish
- 2024-11-14
- Last updated by the study team
- 2025-03-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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
Where it is running
- Tennessee Oncology — Nashville, Tennessee, United States
- University of Texas MD Anderson Cancer Center — Houston, Texas, United States
- Institut Paoli Calmette — Marseille, Bouches Du Rhone, France
- Centre de Lutte Contre le Cancer Gustave Roussy — Villejuif, Val De Marne, France
Full record on ClinicalTrials.gov
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