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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
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
Secondary ID [1] 0 0
2023-504012-16-00
Secondary ID [2] 0 0
TAK-280-1501
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unresectable Locally Advanced or Metastatic Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Dose Limiting Toxicities (DLTs)
Timepoint [1] 0 0
From start of the initial dose up to Cycle 1 Day 28
Primary outcome [2] 0 0
Number of Participants With Treatment- emergent Adverse Events (TEAEs)
Timepoint [2] 0 0
Up to approximately 37 months
Secondary outcome [1] 0 0
Maximum Observed Plasma Concentration (Cmax) of TAK-280
Timepoint [1] 0 0
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)
Secondary outcome [2] 0 0
Area Under Plasma Concentration-Time Curve (AUC) of TAK- 280
Timepoint [2] 0 0
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)
Secondary outcome [3] 0 0
Time to Reach Maximum Observed Plasma Concentration (tmax) of TAK-280
Timepoint [3] 0 0
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)
Secondary outcome [4] 0 0
Terminal Disposition Phase Half-Life (t1/2) of TAK-280
Timepoint [4] 0 0
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)
Secondary outcome [5] 0 0
Total Clearance (CL) of TAK-280
Timepoint [5] 0 0
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)
Secondary outcome [6] 0 0
Volume of Distribution at Steady State (Vss) After IV Administration of TAK-280
Timepoint [6] 0 0
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)
Secondary outcome [7] 0 0
Confirmed Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
Timepoint [7] 0 0
Up to approximately 37 months
Secondary outcome [8] 0 0
Duration of Response (DOR) Based on RECIST V1.1
Timepoint [8] 0 0
Up to approximately 37 months
Secondary outcome [9] 0 0
Progression Free Survival (PFS)
Timepoint [9] 0 0
From start of first dose to disease progression or death, whichever occurred first (up to approximately 37 months)
Secondary outcome [10] 0 0
Overall Survival (OS)
Timepoint [10] 0 0
From start of first dose of study drug up to death (up to approximately 37 months)
Secondary outcome [11] 0 0
Disease Control Rate
Timepoint [11] 0 0
Up to approximately 37 months
Secondary outcome [12] 0 0
Percentage of Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Having Prostate-Specific Antigen (PSA) Response
Timepoint [12] 0 0
Up to approximately 37 months
Secondary outcome [13] 0 0
Duration of PSA Response in Participants With mCRPC
Timepoint [13] 0 0
Up to approximately 37 months
Secondary outcome [14] 0 0
Time to PSA Progression in Participants With mCRPC
Timepoint [14] 0 0
Up to approximately 37 months
Secondary outcome [15] 0 0
Percentage of Participants With mCRPC Having PSA Reductions of >= 50% up to 6 Months
Timepoint [15] 0 0
Baseline up to 6 months
Secondary outcome [16] 0 0
Percentage of Participants who Develop Positive Induced Antidrug Antibody (ADA) for TAK-280
Timepoint [16] 0 0
Cycle 1 to 5: pre-dose (Each cycle= 28 days)
Secondary outcome [17] 0 0
Percentage of Participants who Developed Neutralizing Antibody (NAb) Titers for TAK-280
Timepoint [17] 0 0
Cycle 1 to 5: pre-dose (Each cycle= 28 days)

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
22/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2026
Actual
Sample size
Target
182
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse Hospital - Camperdown
Recruitment hospital [2] 0 0
Southern Oncology Clinical Research Unit - Bedford Park
Recruitment hospital [3] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [4] 0 0
Cabrini Health - Malvern
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
3144 - Malvern
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
Ohio
Country [5] 0 0
United States of America
State/province [5] 0 0
South Dakota
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Wisconsin
Country [9] 0 0
Canada
State/province [9] 0 0
Quebec
Country [10] 0 0
Canada
State/province [10] 0 0
Sherbrooke
Country [11] 0 0
Canada
State/province [11] 0 0
Toronto
Country [12] 0 0
Spain
State/province [12] 0 0
Barcelona
Country [13] 0 0
Spain
State/province [13] 0 0
Madrid
Country [14] 0 0
Spain
State/province [14] 0 0
Malaga
Country [15] 0 0
Spain
State/province [15] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Takeda
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Takeda Development Center Americas, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
Takeda
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Takeda Contact
Address 0 0
Country 0 0
Phone 0 0
+1-877-825-3327
Fax 0 0
Email 0 0
medinfoUS@takeda.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
When will data be available (start and end dates)?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/takeda/


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