A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer
- Registration Number
- NCT04586270
- Lead Sponsor
- Taiho Oncology, Inc.
- Brief Summary
The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 47
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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TAS0612 Escalation TAS0612 TAS0612 administered orally TAS0612 Expansion TAS0612 TAS0612 administered orally
- Primary Outcome Measures
Name Time Method Dose Limiting Toxicities (DLTs) Baseline through Cycle 1 (28-day cycle) Number of participants with DLTs during cycle 1
rPFS rate Baseline through measured progressive disease (estimated up to 12 months) 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.
- Secondary Outcome Measures
Name Time Method Disease Control Rate (DCR) per PCWG3/mRECIST1.1 Baseline through progressive disease or date of death for any causes, whichever comes first, assessed up to 12 months. DCR: Percentage of participants who exhibit stable disease (SD), PR or CR.
Safety and Tolerability From screening to 30 days after last dose All adverse events (AEs) per CTCAE v5.0.
Pharmacodynamic: biochemical effects of TAS0612: Total proteins Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle) Total proteins will be measured in blood samples collected at different time points.
Radiographic Progression Free Survival (rPFS) per PCWG3/mRECIST1.1 Baseline through progressive disease or date of death for any causes, whichever comes first, assessed up to 6 months. Proportion of patients experiencing a radiographic progression by PCWG3/mRECIST1.1 criteria
Duration of Response (DOR) per PCWG3/mRECIST1.1 Baseline through progressive disease or date of death for any causes, whichever comes first, assessed up to 12 months. DOR: Date of PR or CR to date of objective progression or death due to any cause.
Pharmacokinetics (PK) parameters including but not limited to: Cmax Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle) Cycle 2 Day 1 and Cycle 3 Day 1 time of TAS0612 it takes to reach Cmax.
Pharmacokinetics (PK) parameters including but not limited to: Tmax Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle) Cycle 2 Day 1 and Cycle 3 Day 1 time of TAS0612 it takes to reach Cmax,
Pharmacokinetics (PK) parameters including but not limited to: T1/2. Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle) Cycle 2 Day 1 and Cycle 3 Day 1 time it takes for plasma concentration to fall by half its original value (t1/2) of TAS0612
Pharmacodynamic: molecular effects in tumor tissue of TAS0612 Baseline through Day 1 Cycle 2 (28-day cycle) through study completion, an average of 1 year 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.
Overall Response Rate (ORR) per PCWG3/mRECIST1.1 Baseline through progressive disease or date of death for any causes, whichever comes first, assessed up to 12 months. Proportion of patients experiencing a best overall response of Complete Response (CR) or Partial response (PR)
Prostatic Specific Antigen (PSA) Response Baseline to PSA progression, up to 12 months Proportion of patients with ≥50% reduction in PSA from baseline to lowest post-baseline result.
Pharmacokinetics (PK) parameters including but not limited to: AUC. Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle) Cycle 2 Day 1 and Cycle 3 Day 1 Area under the plasma concentration curve of TAS0612.
Pharmacodynamic: biochemical effects of TAS0612: phospho-proteins Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle) 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.
Trial Locations
- Locations (4)
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