A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer
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|ClinicalTrials.gov Identifier: NCT04586270|
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : April 1, 2021
|Condition or disease||Intervention/treatment||Phase|
|Advanced or Metastatic Solid Tumors||Drug: TAS0612||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of TAS0612 in Patients With Locally Advanced or Metastatic Solid Tumors|
|Actual Study Start Date :||October 15, 2020|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||December 2023|
Experimental: TAS0612 Escalation
TAS0612 administered orally
Experimental: TAS0612 Expansion
TAS0612 administered orally
- Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (28 day cycle) ]Number of participants with DLTs during cycle 1
- Objective Response Rate [ Time Frame: Baseline through measured progressive disease (estimated up to 24 months) ]Percentage of participants with partial response (PR) or complete response (CR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Disease Control Rate (DCR) [ Time Frame: Baseline through progressive disease (estimated up to 24 months) ]DCR: Percentage of participants who exhibit stable disease (SD), PR or CR.
- Duration of Response (DOR) [ Time Frame: Estimated up to 22 months ]DOR: Date of PR or CR to date of objective progression or death due to any cause.
- Progression Free Survival (PFS) [ Time Frame: Estimated up to 24 months ]Baseline to objective progression or death due to any cause.
- Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of TAS0612 [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle) ]Cmax of TAS0612
- Pharmacokinetics (PK): plasma concentration of TAS0612 [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle) ]Plasma concentration of TAS0612
- PK: Area under the plasma concentration curve (AUC) [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle) ]AUC of TAS0612
- PK: Time it takes to reach Cmax (Tmax) of TAS0612 [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle) ]Tmax of TAS0612
- PK: Time it takes for plasma concentration to fall by half its original value (t1/2) of TAS0612 [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle) ]t1/2 of TAS0612
- Safety and Tolerability [ Time Frame: Estimated up to 24 months ]All adverse events (AEs) per CTCAE v5.0
- Pharmacodynamic: biochemical effects of TAS0612 [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle) ]Total proteins and 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.
- Pharmacodynamic: molecular effects in tumor tissue of TAS0612 [ Time Frame: Baseline through Day 1 Cycle 2 (28-day cycle) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586270
|Contact: Jill Kremer, MDemail@example.com|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Centre de Lutte Contre le Cancer Gustave Roussy||Recruiting|
|Villejuif, Cedex, France, 94805|