Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

TAS0612

Taiho Oncology, INC

Erika Hamilton

Funda Meric-Bernstam

Capucine Baldini

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

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

Structure elucidation of TAS0612 metabolites in human plasma.

To explore the correlation between the incidence of exposures of TAS0612 in plasma and QT prolongation

To investigate potential predictive biomarkers for TAS0612.

To explore the correlation between PK and antitumor activity or toxicity

Number of participants with DLTs during cycle 1

Percentage of participants with partial response (PR) or complete response (CR) at 6 months Prostate Cancer Working Group 3 (PCWG3)/ modified defined by the Response Evaluation Criteria in Solid Tumors (mRECIST) v1.1.

DCR: Percentage of participants who exhibit stable disease (SD), PR or CR.

DOR: Date of PR or CR to date of objective progression or death due to any cause.

Proportion of patients experiencing a radiographic progression by PCWG3/mRECIST1.1 criteria

Proportion of patients experiencing a best overall response of Complete Response (CR) or Partial response (PR)

Proportion of patients with ≥50% reduction in PSA from baseline to lowest post-baseline result.

Area under the plasma concentration curve of TAS0612.

time it takes for plasma concentration to fall by half its original value (t1/2) of TAS0612

Total proteins will be measured in blood samples collected at different time points.

Phospho-proteins will be measured in blood samples collected at different time points. The levels/changes (dose- and concentration-dependent) of phospho-proteins will be assessed and reported for biochemical effects of TAS0612.

Selected phospho-proteins will be analyzed in tumor tissue at baseline and on-treatment in dose escalation. The levels/changes of the phospho-proteins will be assessed and reported for target modulation.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer	NCT04586270	Advanced or Met...	TAS0612	18 Years -	Taiho Oncology, Inc.
A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer	NCT04586270	Advanced or Met...	TAS0612	18 Years -	Taiho Oncology, Inc.

Spots Global Cancer Trial Database for tas0612

Every month we try and update this database with for tas0612 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tas0612

Every month we try and update this database with for tas0612 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tas0612 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.