A Phase 1 Study of TAS0612 in Patients With Locally Advanced or Metastatic Solid Tumors

Taiho Oncology, Inc.4 sites in 2 countries47 target enrollmentOctober 15, 2020

ConditionsAdvanced or Metastatic Solid Tumors

InterventionsTAS0612

DrugsTAS0612

Overview

Phase: Phase 1
Intervention: TAS0612
Conditions: Advanced or Metastatic Solid Tumors
Sponsor: Taiho Oncology, Inc.
Enrollment: 47
Locations: 4
Primary Endpoint: Dose Limiting Toxicities (DLTs)
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

October 15, 2020

End Date

November 14, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Taiho Oncology, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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 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

Arms & Interventions

TAS0612 Escalation

TAS0612 administered orally

Intervention: TAS0612

TAS0612 Expansion

TAS0612 administered orally

Intervention: TAS0612

Outcomes

Primary Outcomes

Dose Limiting Toxicities (DLTs)

Time Frame: Baseline through Cycle 1 (28-day cycle)

Number of participants with DLTs during cycle 1

rPFS rate

Time Frame: 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 Outcomes

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.)
Safety and Tolerability(From screening to 30 days after last dose)
Pharmacodynamic: biochemical effects of TAS0612: Total proteins(Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle))
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.)
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.)
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)
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)
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)
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)
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.)
Prostatic Specific Antigen (PSA) Response(Baseline to PSA progression, up to 12 months)
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)
Pharmacodynamic: biochemical effects of TAS0612: phospho-proteins(Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle))