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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-002304-39 | EudraCT Number |
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Taiho Oncology as the sponsor of study TAS0612-101, has made a strategic decision to terminate the TAS0612-101 study, taking into consideration the safety profile of TAS0612 and the absence of encouraging anti-tumor activity.
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The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAS0612 Escalation | Experimental | TAS0612 administered orally |
|
| TAS0612 Expansion | Experimental | TAS0612 administered orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAS0612 | Drug | oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Control Rate (DCR) per PCWG3/mRECIST1.1 | DCR: Percentage of participants who exhibit stable disease (SD), PR or CR. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Metabolites in plasma | Structure elucidation of TAS0612 metabolites in human 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 |
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:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States | ||
| University of Texas MD Anderson Cancer Center |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 27, 2025 | |
| Reset | Nov 11, 2025 | |
| Release | Dec 5, 2025 | |
| Reset | Dec 22, 2025 | |
| Release | Jan 23, 2026 | |
| Reset | Feb 10, 2026 | |
| Release | Mar 13, 2026 | |
| Reset | Apr 1, 2026 | |
| Release | Apr 22, 2026 | |
| Reset | May 13, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 27, 2025 | Nov 11, 2025 | |||
| Dec 5, 2025 |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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DOR: Date of PR or CR to date of objective progression or death due to any cause. |
| 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 | Proportion of patients experiencing a radiographic progression by PCWG3/mRECIST1.1 criteria | 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 | Proportion of patients experiencing a best overall response of Complete Response (CR) or Partial response (PR) | Baseline through progressive disease or date of death for any causes, whichever comes first, assessed up to 12 months. |
| Prostatic Specific Antigen (PSA) Response | Proportion of patients with ≥50% reduction in PSA from baseline to lowest post-baseline result. | Baseline to PSA progression, up to 12 months |
| Pharmacokinetics (PK) parameters including but not limited to: Cmax | time of TAS0612 it takes to reach 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 | time of TAS0612 it takes to reach 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: AUC. | Area under the plasma concentration curve of TAS0612. | 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. | time it takes for plasma concentration to fall by half its original value (t1/2) of TAS0612 | Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle) Cycle 2 Day 1 and Cycle 3 Day 1 |
| Safety and Tolerability | All adverse events (AEs) per CTCAE v5.0. | From screening to 30 days after last dose |
| Pharmacodynamic: biochemical effects of TAS0612: Total proteins | Total proteins will be measured in blood samples collected at different time points. | Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle) |
| Pharmacodynamic: biochemical effects of TAS0612: phospho-proteins | 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. | Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle) |
| Pharmacodynamic: molecular effects in tumor tissue of TAS0612 | 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. | Baseline through Day 1 Cycle 2 (28-day cycle) through study completion, an average of 1 year |
To explore the correlation between the incidence of exposures of TAS0612 in plasma and QT prolongation
| 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 | To investigate potential predictive biomarkers for TAS0612. | Baseline through progressive disease or date of death for any causes, whichever comes first, assessed up to 12 months. |
| Exposure of TAS0612 and selected efficacy and safety measures. | To explore the correlation between PK and antitumor activity or toxicity | Baseline through progressive disease or date of death for any causes, whichever comes first, assessed up to 12 months. |
| Houston |
| Texas |
| 77030 |
| United States |
| Institut Paoli Calmette | Marseille | Bouches Du Rhone | 13009 | France |
| Centre de Lutte Contre le Cancer Gustave Roussy | Villejuif | Val De Marne | 94805 | France |
| Dec 22, 2025 |
| Jan 23, 2026 | Feb 10, 2026 |
| Mar 13, 2026 | Apr 1, 2026 |
| Apr 22, 2026 | May 13, 2026 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |