Advanced or Metastatic Solid TumorsPhase 1NCT04586270
A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer
A Phase 1 study testing TAS0612 in people with Advanced or Metastatic Solid Tumors, run by Taiho Oncology, Inc. at 4 sites in 2 countries.
Trial summary
The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- TAS0612
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 15 Oct 2020to 14 Nov 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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
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- Unable to swallow or digest pills
- Poorly controlled diabetes
- Concomitant medications or substances that are strong inhibitors/inducers of CYP3A.Study
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States2 sites
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Tennessee Oncology
Nashville, Tennessee, 37203
France2 sites
Institut Paoli Calmette
Marseille, Bouches Du Rhone, 13009
Centre de Lutte Contre le Cancer Gustave Roussy
Villejuif, Val De Marne, 94805
About this study
Official title: A Phase 1 Study of TAS0612 in Patients With Locally Advanced or Metastatic Solid Tumors
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
- Being tested
- TAS0612
- Keywords
- Solid Tumors, AKT inhibitor, RSK inhibitor, S6K inhibitor, kinase inhibitor, phase I, Prostate cancer, PTEN loss, PTEN mutation
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS0612Drug
oral tablets
| Study group | Role | What they receive |
|---|---|---|
| TAS0612 Escalation | Experimental | TAS0612 administered orally Receives: Drug: TAS0612 |
| TAS0612 Expansion | Experimental | TAS0612 administered orally Receives: Drug: TAS0612 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLTs)
Number of participants with DLTs during cycle 1
Measured: 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.
Measured: Baseline through measured progressive disease (estimated up to 12 months)
Secondary outcomes (13)
Disease Control Rate (DCR) per PCWG3/mRECIST1.1
DCR: Percentage of participants who exhibit stable disease (SD), PR or CR.
Measured: 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
DOR: Date of PR or CR to date of objective progression or death due to any cause.
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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,
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline through Day 1 Cycle 2 (28-day cycle) through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start15 Oct 2020
- Primary completion14 Nov 2024
- Study completion14 Nov 2024
Why it stopped: 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by Taiho Oncology, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Oncology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586270
- Sponsor's protocol ID
- TAS0612-101
- Other IDs
- 2020-002304-39
- Status last verified
- Mar 2025
- First submitted
- 23 Sep 2020
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of TAS0612 in Patients With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04586270
- Acronym / sponsor ID
- TAS0612-101
- Conditions
- Advanced or Metastatic Solid Tumors
- Keywords
- Solid Tumors, AKT inhibitor, RSK inhibitor, S6K inhibitor, kinase inhibitor, phase I, Prostate cancer, PTEN loss
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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.
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Taiho Oncology, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 14 Nov 2024 (actual)
- Study completion
- 14 Nov 2024 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAS0612 Escalation | Experimental | Drug: TAS0612TAS0612 administered orally |
| TAS0612 Expansion | Experimental | Drug: TAS0612TAS0612 administered orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS0612oral tablets | Drug | TAS0612 Escalation, TAS0612 Expansion |
Primary outcome
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.
13 secondary outcomes
Disease Control Rate (DCR) per PCWG3/mRECIST1.1
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline through progressive disease or date of death for any causes, whichever comes first, assessed up to 12 months.
Prostatic Specific Antigen (PSA) Response
Time frame: Baseline to PSA progression, up to 12 months
Pharmacokinetics (PK) parameters including but not limited to: Cmax
Time frame: 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 frame: 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.
Time frame: 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 frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle) Cycle 2 Day 1 and Cycle 3 Day 1
Safety and Tolerability
Time frame: From screening to 30 days after last dose
Pharmacodynamic: biochemical effects of TAS0612: Total proteins
Time frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle)
Pharmacodynamic: biochemical effects of TAS0612: phospho-proteins
Time frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle)
Pharmacodynamic: molecular effects in tumor tissue of TAS0612
Time frame: Baseline through Day 1 Cycle 2 (28-day cycle) through study completion, an average of 1 year
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAS0612 in people with Advanced or Metastatic Solid Tumors, run by Taiho Oncology, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLTs) (time frame: Baseline through Cycle 1 (28-day cycle)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.