Description:
The purpose of this study is to see if TAS0612 is safe in participants with advanced or
metastatic solid tumor cancer.
Title
- Brief Title: A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer
- Official Title: A Phase 1 Study of TAS0612 in Patients With Locally Advanced or Metastatic Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
TAS0612-101
- SECONDARY ID:
2020-002304-39
- NCT ID:
NCT04586270
Conditions
- Advanced or Metastatic Solid Tumors
Interventions
Drug | Synonyms | Arms |
---|
TAS0612 | | TAS0612 Escalation |
Purpose
The purpose of this study is to see if TAS0612 is safe in participants with advanced or
metastatic solid tumor cancer.
Trial Arms
Name | Type | Description | Interventions |
---|
TAS0612 Escalation | Experimental | TAS0612 administered orally | |
TAS0612 Expansion | Experimental | TAS0612 administered orally | |
Eligibility Criteria
Inclusion Criteria:
- Dose Escalation: have evidence of a solid tumor that is locally advanced and/or
metastatic (excluding primary brain tumor)
- Dose Expansion: have evidence of a solid tumor as outlined below that is locally
advanced and/or metastatic (excluding primary brain tumor)
- Cohort A: Human epidermal growth factor negative (HER2 negative) Breast Cancer
with an NF1 mutation
- Cohort B: Hormone receptor positive (HR+)/HER2 negative breast cancer after
progression on endocrine therapy and a CDK4/6 inhibitor
- Cohort C: PTEN loss or mutations
- Cohort D: KRAS G12C mutation
- Cohort E: KRAS G12D mutation
- Have adequate organ function
- Amenable to biopsy
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG)
scale
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Dose Limiting Toxicities (DLTs) |
Time Frame: | Baseline through Cycle 1 (28 day cycle) |
Safety Issue: | |
Description: | Number of participants with DLTs during cycle 1 |
Secondary Outcome Measures
Measure: | Disease Control Rate (DCR) |
Time Frame: | Baseline through progressive disease (estimated up to 24 months) |
Safety Issue: | |
Description: | DCR: Percentage of participants who exhibit stable disease (SD), PR or CR. |
Measure: | Duration of Response (DOR) |
Time Frame: | Estimated up to 22 months |
Safety Issue: | |
Description: | DOR: Date of PR or CR to date of objective progression or death due to any cause. |
Measure: | Progression Free Survival (PFS) |
Time Frame: | Estimated up to 24 months |
Safety Issue: | |
Description: | Baseline to objective progression or death due to any cause. |
Measure: | Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of TAS0612 |
Time Frame: | Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle) |
Safety Issue: | |
Description: | Cmax of TAS0612 |
Measure: | Pharmacokinetics (PK): plasma concentration of TAS0612 |
Time Frame: | Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle) |
Safety Issue: | |
Description: | Plasma concentration of TAS0612 |
Measure: | PK: Area under the plasma concentration curve (AUC) |
Time Frame: | Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle) |
Safety Issue: | |
Description: | AUC of TAS0612 |
Measure: | PK: Time it takes to reach Cmax (Tmax) of TAS0612 |
Time Frame: | Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle) |
Safety Issue: | |
Description: | Tmax of TAS0612 |
Measure: | PK: Time it takes for plasma concentration to fall by half its original value (t1/2) of TAS0612 |
Time Frame: | Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle) |
Safety Issue: | |
Description: | t1/2 of TAS0612 |
Measure: | Safety and Tolerability |
Time Frame: | Estimated up to 24 months |
Safety Issue: | |
Description: | All adverse events (AEs) per CTCAE v5.0 |
Measure: | Pharmacodynamic: biochemical effects of TAS0612 |
Time Frame: | Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle) |
Safety Issue: | |
Description: | Total proteins and 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. |
Measure: | Pharmacodynamic: molecular effects in tumor tissue of TAS0612 |
Time Frame: | Baseline through Day 1 Cycle 2 (28-day cycle) |
Safety Issue: | |
Description: | 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. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Taiho Oncology, Inc. |
Trial Keywords
- Solid Tumors
- AKT inhibitor
- RSK inhibitor
- S6K inhibitor
- kinase inhibitor
- phase I
- phase 1
- NF1 mutation
- endocrine therapy resistance
- PTEN loss
- PTEN mutation
- KRAS G12C
- KRAS G12D
- breast cancer
Last Updated
April 1, 2021