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

NCT04586270 | Terminated Phase 1 FDA Drug

• 2 other identifiers: TAS0612-1012020-002304-39
• Study Type: interventional
• Target: 47
• Locations: 2 countries
• Sites: 4

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

Keywords

Solid Tumors; AKT inhibitor; RSK inhibitor; S6K inhibitor; kinase inhibitor; phase I; Prostate cancer; PTEN loss; PTEN mutation

Outcome Measures

Primary Outcomes (2)

• Dose Limiting Toxicities (DLTs)

  Number of participants with DLTs during cycle 1

  Baseline through Cycle 1 (28-day cycle)

• rPFS rate

  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.

  Baseline through measured progressive disease (estimated up to 12 months)

Secondary Outcomes (13)

• 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.

• 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.

• 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.

• 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

Other Outcomes (4)

• Pharmacokinetics (PK): Metabolites in plasma

  Cycle 1 Day 1 (each cycle is 28 days).

• Time-matched plasma exposures of TAS0612 and changes from baseline in QTcF using central ECG measurements

  Baseline through progressive disease or date of death for any causes, whichever comes first, assessed up to 12 months

• Exploratory correlation of tissue and/or blood markers with tumor efficacy endpoints and/or tumor resistance to TAS0612

  Baseline through progressive disease or date of death for any causes, whichever comes first, assessed up to 12 months.

Study Arms (2)

TAS0612 Escalation

EXPERIMENTAL

TAS0612 administered orally

Drug: TAS0612

TAS0612 Expansion

EXPERIMENTAL

TAS0612 administered orally

Drug: TAS0612

Interventions

TAS0612 DRUG

oral tablets

TAS0612 Escalation; TAS0612 Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead

Study Sites (4)

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Institut Paoli Calmette

Marseille, Bouches Du Rhone, 13009, France

Location

Centre de Lutte Contre le Cancer Gustave Roussy

Villejuif, Val De Marne, 94805, France

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: October 14, 2020
• Study Start: October 15, 2020
• Primary Completion: November 14, 2024
• Study Completion: November 14, 2024
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); US (2)