Clinical Trials /

A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer

NCT04586270

Description:

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

Related Conditions:
  • Breast Carcinoma
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

DrugSynonymsArms
TAS0612TAS0612 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

NameTypeDescriptionInterventions
TAS0612 EscalationExperimentalTAS0612 administered orally
  • TAS0612
TAS0612 ExpansionExperimentalTAS0612 administered orally
  • TAS0612

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:Not yet 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

October 13, 2020