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

NCT ID: NCT04586270

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2024-11-14

Brief Summary

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

Conditions

Advanced or Metastatic Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TAS0612 Escalation

TAS0612 administered orally

Group Type: EXPERIMENTAL

TAS0612

Intervention Type: DRUG

oral tablets

TAS0612 Expansion

TAS0612 administered orally

Group Type: EXPERIMENTAL

TAS0612

Intervention Type: DRUG

oral tablets

Interventions

TAS0612

oral tablets

Intervention Type: DRUG

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) 1.1.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taiho Oncology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; France

Other Identifiers

2020-002304-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

TAS0612-101

Identifier Type: -

Identifier Source: org_study_id