A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer
Megadott ok: 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.
Key facts
- Where
- Marseille és Villejuif, FranciaországSee the 2 sites
- Phase
- 1. fázis
Where in Franciaország
- Institut Paoli-CalmetteMarseille, FranciaországNo longer taking part
- Centre de Lutte Contre le Cancer Gustave RoussyVillejuif, FranciaországNo longer taking part
Trial details
- Who runs it
- Taiho Oncology, Inc.
- Trial code
- NCT04586270
- Record updated
- 2025. március 13.
- Original description
The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.Read full original descriptionShow less
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: 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: Have not discontinued or recovered from previous treatments for cancer; Have a serious concomitant disorder; Concomitant medications or substances that are strong inhibitors/inducers of CYP3A.Study; Have a significant cardiac condition; Poorly controlled diabetes; Participating in medical research not compatible with this study; Have untreated brain metastases; Have a primary brain tumor; Unable to swallow or digest pills.