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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05220098
Registration number
NCT05220098
Ethics application status
Date submitted
7/01/2022
Date registered
2/02/2022
Titles & IDs
Public title
First-in-Human Study of TAK-280 in Participants With Solid Tumors
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Scientific title
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer
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Secondary ID [1]
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2023-504012-16
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Secondary ID [2]
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TAK-280-1501
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Unresectable Locally Advanced or Metastatic Cancer
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - TAK-280
Experimental: Dose-escalation Phase: TAK-280 - Participants will receive TAK-280 intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
Experimental: Cohort-expansion Phase: TAK-280 High or low Dose - Participants will receive either TAK-280 high or low dose in one selected indication and only one dose level of TAK-280 in the remaining indications as determined from the dose-escalation phase of the study in 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
Treatment: Drugs: TAK-280
Participants will receive TAK-280 as IV infusion.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Dose Limiting Toxicities (DLTs)
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Assessment method [1]
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DLT evaluation period is defined as the time between the initial dose of TAK-280 and Cycle 1 Day 28.
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Timepoint [1]
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From start of the initial dose up to Cycle 1 Day 28
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Primary outcome [2]
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Number of Participants With Treatment- emergent Adverse Events (TEAEs)
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Assessment method [2]
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Timepoint [2]
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Up to approximately 37 months
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Secondary outcome [1]
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Maximum Observed Plasma Concentration (Cmax) of TAK-280
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Assessment method [1]
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Cmax of TAK-280 will be reported.
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Timepoint [1]
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Pre-dose and at multiple time points post-dose on Days 1, 2, 3, 8, 15, 22 up to the end of treatment (Up to 14 months)
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Secondary outcome [2]
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Area Under Plasma Concentration-Time Curve (AUC) of TAK- 280
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Assessment method [2]
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AUC of TAK-280 will be reported.
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Timepoint [2]
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Pre-dose and at multiple time points post-dose on Days 1, 2, 3, 8, 15, 22 up to the end of treatment (Up to 14 months)
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Secondary outcome [3]
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Time to Reach Maximum Observed Plasma Concentration (tmax) of TAK-280
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Assessment method [3]
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tmax of TAK-280 will be reported.
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Timepoint [3]
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Pre-dose and at multiple time points post-dose on Days 1, 2, 3, 8, 15, 22 up to the end of treatment (Up to 14 months)
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Secondary outcome [4]
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Terminal Disposition Phase Half-Life (t1/2) of TAK-280
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Assessment method [4]
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t1/2 of TAK-280 will be reported.
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Timepoint [4]
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Pre-dose and at multiple time points post-dose on Days 1, 2, 3, 8, 15, 22 up to the end of treatment (Up to 14 months)
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Secondary outcome [5]
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Total Clearance (CL) of TAK-280
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Assessment method [5]
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CL of TAK-280 will be reported.
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Timepoint [5]
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Pre-dose and at multiple time points post-dose on Days 1, 2, 3, 8, 15, 22 up to the end of treatment (Up to 14 months)
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Secondary outcome [6]
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Volume of Distribution at Steady State (Vss) After IV Administration of TAK-280
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Assessment method [6]
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Vss of TAK-280 will be reported.
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Timepoint [6]
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Pre-dose and at multiple time points post-dose on Days 1, 2, 3, 8, 15, 22 up to the end of treatment (Up to 14 months)
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Secondary outcome [7]
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Confirmed Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
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Assessment method [7]
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ORR is defined as the percentage of participants who achieve confirmed complete response (CR) or partial response (PR) based on RECIST V1.1 as determined by the investigator during the study.
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Timepoint [7]
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Up to approximately 37 months
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Secondary outcome [8]
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Duration of Response (DOR) Based on RECIST V1.1
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Assessment method [8]
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DOR is defined as the time from the date of first documentation of a PR or better to the date of first documentation of progressive disease (PD) or death due to any cause, whichever occurs first, for participants with a confirmed response (PR or better).
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Timepoint [8]
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Up to approximately 37 months
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Secondary outcome [9]
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Progression Free Survival (PFS)
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Assessment method [9]
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PFS is defined as the time from the date of the first dose of TAK-280 to the date of first documentation of PD or death due to any cause, whichever occurs first.
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Timepoint [9]
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From start of first dose to disease progression or death, whichever occurred first (up to approximately 37 months)
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Secondary outcome [10]
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Overall Survival (OS)
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Assessment method [10]
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OS is defined as the time from the date of the first dose of TAK-280 to the date of death due to any cause.
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Timepoint [10]
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From start of first dose of study drug up to death (up to approximately 37 months)
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Secondary outcome [11]
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Disease Control Rate
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Assessment method [11]
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Disease control rate is defined as the percentage of participants who achieve PR or CR or SD, with a duration of greater than or equal to (\>=) 2 consecutive scans.
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Timepoint [11]
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Up to approximately 37 months
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Secondary outcome [12]
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Percentage of Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Having Prostate-Specific Antigen (PSA) Response
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Assessment method [12]
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PSA response is defined as PSA reduction from baseline of \>= 50 percent (%) and confirmed at least 3 weeks later.
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Timepoint [12]
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Up to approximately 37 months
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Secondary outcome [13]
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Duration of PSA Response in Participants With mCRPC
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Assessment method [13]
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Duration of PSA response is defined as the time from first PSA response to first documented PSA progression.
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Timepoint [13]
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Up to approximately 37 months
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Secondary outcome [14]
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Time to PSA Progression in Participants With mCRPC
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Assessment method [14]
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Time to PSA progression is defined as the time from the date of first dose of TAK-280 to the date that an increase of 25% or more and absolute increase of 2 nanograms/milliliter (ng/mL) or more from the nadir.
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Timepoint [14]
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Up to approximately 37 months
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Secondary outcome [15]
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Percentage of Participants With mCRPC Having PSA Reductions of >= 50% up to 6 Months
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Assessment method [15]
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Timepoint [15]
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Baseline up to 6 months
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Secondary outcome [16]
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Percentage of Participants who Develop Positive Induced Antidrug Antibody (ADA) for TAK-280
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Assessment method [16]
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Timepoint [16]
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Cycle 1 to 5: pre-dose (Each cycle= 28 days)
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Secondary outcome [17]
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Percentage of Participants who Developed Neutralizing Antibody (NAb) Titers for TAK-280
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Assessment method [17]
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Timepoint [17]
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Cycle 1 to 5: pre-dose (Each cycle= 28 days)
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Eligibility
Key inclusion criteria
Inclusion Criteria
* Age greater than or equal to (>=)18 years or >= the local legal age of majority, as applicable.
* Criteria for disease state in dose escalation and cohort expansion.
1. Tumor histologies during dose escalation: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers.
2. Tumor histologies during cohort expansion: Participants will be eligible if they have histologically proven, unresectable, locally advanced or metastatic malignant neoplasms.
* Eastern Cooperative Oncology Group performance status (less than or equal to [<=]) 1.
* Measurable disease per RECIST V1.1 by investigator except for participants with mCRPC with bone metastases only (these participants are allowed in the study). Lesions in previously irradiated areas (or other local therapy) should not be selected as measurable/target lesions, unless treatment was >=6 months prior to start of treatment or there has been demonstrated progression with a clear margin to measure in that particular lesion.
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Minimum age
18
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria
* History of known autoimmune disease.
* Major surgery or traumatic injury within 8 weeks before the first dose of TAK-280.
* Unhealed wounds from surgery or injury.
* Ongoing or active infection of Grade >=2.
* Oxygen saturation less than (<) 92 percent (%) on room air at screening or during Cycle 1 Day 1 (C1D1) predose assessment.
* Inflammatory process that has not resolved for >= 4 weeks before the first dose of study drug. Participants with chronic low-grade inflammatory processes such as radiation-induced pneumonitis are excluded regardless of their duration.
* Vaccination with any live virus vaccine within 4 weeks or other vaccines within 2 weeks before the initiation of study drug administration. Inactivated annual influenza vaccination is allowed.
* Known hypersensitivity to TAK-280 or any excipient.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/04/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2026
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Actual
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Sample size
Target
182
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Chris O'Brien Lifehouse Hospital - Camperdown
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Recruitment hospital [2]
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Southern Oncology Clinical Research Unit - Bedford Park
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Recruitment hospital [3]
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Monash Medical Centre - Clayton
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Recruitment hospital [4]
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Cabrini Health - Malvern
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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5042 - Bedford Park
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Recruitment postcode(s) [3]
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3168 - Clayton
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Recruitment postcode(s) [4]
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3144 - Malvern
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Minnesota
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Country [4]
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United States of America
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State/province [4]
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Ohio
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Country [5]
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United States of America
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State/province [5]
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South Dakota
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Country [6]
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United States of America
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State/province [6]
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Tennessee
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Country [7]
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United States of America
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State/province [7]
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Wisconsin
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Country [8]
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Canada
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State/province [8]
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Quebec
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Country [9]
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Canada
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State/province [9]
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Sherbrooke
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Country [10]
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Canada
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State/province [10]
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Toronto
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Country [11]
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Spain
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State/province [11]
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Barcelona
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Country [12]
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Spain
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State/province [12]
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Madrid
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Country [13]
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Spain
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State/province [13]
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Malaga
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Country [14]
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Spain
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State/province [14]
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Valencia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Takeda
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Takeda Development Center Americas, Inc.
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The main aim of this study is to find out the safety, tolerability, and effect of TAK- 280 in participants with unresectable, locally advanced or metastatic cancer who have experienced treatment failure or are intolerant to standard therapies. Participants will be treated with TAK-280 for up to 14 treatment cycles. Each treatment cycle will be 28 days. After the last dose of study drug, participants will be followed up for survival every 12 weeks for a total of 48 weeks.
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Trial website
https://clinicaltrials.gov/study/NCT05220098
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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Takeda
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Takeda Contact
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Address
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Country
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Phone
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+1-877-825-3327
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
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Available to whom?
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05220098