Clinical trial · Interventional
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
NCT04586270CI-TRIAL-00087180terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Taiho Oncology as the sponsor of study TAS0612-101, has made a strategic decision to terminate the TAS0612-101 study, taking into consideration the safety profile of TAS0612 and the absence of encouraging anti-tumor activity.
Summary
Brief summary (as posted)
The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TAS0612 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TAS0612 Escalation
- description
- TAS0612 administered orally
- interventionNames
- Drug: TAS0612
- type
- EXPERIMENTAL
- label
- TAS0612 Expansion
- description
- TAS0612 administered orally
- interventionNames
- Drug: TAS0612
Primary outcomes (2)
- measure
- Dose Limiting Toxicities (DLTs)
- timeFrame
- Baseline through Cycle 1 (28-day cycle)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.