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First-in-Human Study of TAK-280 in Participants With Unresectable Locally Advanced or Metastatic Cancer

Primary Purpose

Unresectable Locally Advanced or Metastatic Cancer

Status
Recruiting
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
TAK-280
Sponsored by
Takeda
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unresectable Locally Advanced or Metastatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  • Age greater than or equal to (>=)18 years.
  • Criteria for disease state.

    1. Dose-escalation tumor histologies: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers.
    2. Cohort-expansion tumor histologies: 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 modified Response Evaluation Criteria in Solid Tumors (mRECIST) Version 1.1 and documented by CT and/or MRI except for participants with PC with only bone metastases.

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 < 92% on room air at screening or during C1D1 predose assessment.
  • Inflammatory process that has not resolved >= 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. Inactivated annual influenza vaccination is allowed.
  • Known hypersensitivity to TAK-280 or any excipient.

Sites / Locations

  • Southern Oncology Clinical Research UnitRecruiting
  • Monash Medical CentreRecruiting
  • Cabrini HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dose-escalation Phase: TAK-280

Cohort-expansion Phase: TAK-280 High or low Dose

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment- emergent Adverse Events (TEAEs)
Number of Participants With Dose Limiting Toxicities (DLTs)
DLT evaluation period is defined as the time between the initial dose of TAK-280 and Cycle 1 Day 28.

Secondary Outcome Measures

Maximum Observed Plasma Concentration (Cmax) of TAK-280
Cmax of TAK-280 will be reported.
Area Under Plasma Concentration-Time Curve (AUC) of TAK- 280
AUC of TAK-280 will be reported.
Time to Reach Maximum Observed Plasma Concentration (tmax) of TAK-280
tmax of TAK-280 will be reported.
Terminal Disposition Phase Half-Life (t1/2) of TAK-280
t1/2 of TAK-280 will be reported.
Total Clearance (CL) of TAK-280
CL of TAK-280 will be reported.
Volume of Distribution at Steady State After Intravenous Administration (Vss) of TAK-280
VSS of TAK-280 will be reported.
Percentage of Participants With Confirmed Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
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.
Duration of Response (DOR) Based on RECIST V1.1
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).
Progression Free Survival (PFS)
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.
Overall Survival (OS)
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.
Disease Control Rate
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.
Percentage of Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Having Prostate-Specific Antigen (PSA) Response
PSA response is defined as PSA reduction from baseline of >= 50 percent (%) and confirmed at least 3 weeks later.
Duration of PSA Response in Participants With mCRPC
Duration of PSA response is defined as the time from first PSA response to first documented PSA progression.
Time to PSA Progression in Participants With mCRPC
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.
Percentage of Participants With mCRPC Having PSA Reductions of >= 50% up to 6 Months
Percentage of Participants who Develop Positive Induced Antidrug Antibody (ADA) for TAK-280
Percentage of Participants who Developed Neutralizing Antibody (NAb) Titers for TAK-280

Full Information

First Posted
January 7, 2022
Last Updated
August 23, 2023
Sponsor
Takeda
Collaborators
Takeda Development Center Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05220098
Brief Title
First-in-Human Study of TAK-280 in Participants With Unresectable Locally Advanced or Metastatic Cancer
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2022 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
July 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
Collaborators
Takeda Development Center Americas, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study consists of 2 phases: Dose-escalation and cohort-expansion phase. Dose-escalation phase: The purpose of the dose-escalation phase is to generate data to characterize the initial safety and tolerability profile of TAK-280 and determine the 2 recommended doses for expansion (RDEs) of TAK-280 to be administered during the cohort-expansion phase. Cohort-Expansion Phase: The cohort expansion phase will be conducted in 3 indications. Only in 1 selected indication participants will be randomized 1:1 to receive either TAK-280 high dose or low dose. In the remaining 2 indications to be studied in the cohort-expansion phase, participants will receive only one dose level of TAK-280.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unresectable Locally Advanced or Metastatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Model Description
Dose-escalation Phase is non-randomized and Cohort-expansion Phase will include randomized and non-randomized cohorts.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose-escalation Phase: TAK-280
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort-expansion Phase: TAK-280 High or low Dose
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
TAK-280
Intervention Description
Participants will receive TAK-280 as IV infusion.
Primary Outcome Measure Information:
Title
Number of Participants With Treatment- emergent Adverse Events (TEAEs)
Time Frame
Up to approximately 37 months
Title
Number of Participants With Dose Limiting Toxicities (DLTs)
Description
DLT evaluation period is defined as the time between the initial dose of TAK-280 and Cycle 1 Day 28.
Time Frame
From start of the initial dose up to Cycle 1 Day 28
Secondary Outcome Measure Information:
Title
Maximum Observed Plasma Concentration (Cmax) of TAK-280
Description
Cmax of TAK-280 will be reported.
Time Frame
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)
Title
Area Under Plasma Concentration-Time Curve (AUC) of TAK- 280
Description
AUC of TAK-280 will be reported.
Time Frame
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)
Title
Time to Reach Maximum Observed Plasma Concentration (tmax) of TAK-280
Description
tmax of TAK-280 will be reported.
Time Frame
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)
Title
Terminal Disposition Phase Half-Life (t1/2) of TAK-280
Description
t1/2 of TAK-280 will be reported.
Time Frame
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)
Title
Total Clearance (CL) of TAK-280
Description
CL of TAK-280 will be reported.
Time Frame
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)
Title
Volume of Distribution at Steady State After Intravenous Administration (Vss) of TAK-280
Description
VSS of TAK-280 will be reported.
Time Frame
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)
Title
Percentage of Participants With Confirmed Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1)
Description
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.
Time Frame
Up to approximately 37 months
Title
Duration of Response (DOR) Based on RECIST V1.1
Description
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).
Time Frame
Up to approximately 37 months
Title
Progression Free Survival (PFS)
Description
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.
Time Frame
From start of first dose to disease progression or death, whichever occurred first (up to approximately 37 months)
Title
Overall Survival (OS)
Description
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.
Time Frame
From start of first dose of study drug up to death (up to approximately 37 months)
Title
Disease Control Rate
Description
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.
Time Frame
Up to approximately 37 months
Title
Percentage of Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Having Prostate-Specific Antigen (PSA) Response
Description
PSA response is defined as PSA reduction from baseline of >= 50 percent (%) and confirmed at least 3 weeks later.
Time Frame
Up to approximately 37 months
Title
Duration of PSA Response in Participants With mCRPC
Description
Duration of PSA response is defined as the time from first PSA response to first documented PSA progression.
Time Frame
Up to approximately 37 months
Title
Time to PSA Progression in Participants With mCRPC
Description
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.
Time Frame
Up to approximately 37 months
Title
Percentage of Participants With mCRPC Having PSA Reductions of >= 50% up to 6 Months
Time Frame
Baseline up to 6 months
Title
Percentage of Participants who Develop Positive Induced Antidrug Antibody (ADA) for TAK-280
Time Frame
Cycle 1 to 5: pre-dose (Each cycle= 28 days)
Title
Percentage of Participants who Developed Neutralizing Antibody (NAb) Titers for TAK-280
Time Frame
Cycle 1 to 5: pre-dose (Each cycle= 28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. Tumor histologies during dose escalation: Dose escalation will begin by initially enrolling participants with histologically or pathologically confirmed, unresectable, locally advanced or metastatic cancers. 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 PC and only bone metastases (these participants are allowed in the study). 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. Inactivated annual influenza vaccination is allowed. Known hypersensitivity to TAK-280 or any excipient.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Southern Oncology Clinical Research Unit
City
Bedford Park
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+61491679039
Email
ganessan.kichenadasse@socru.org.au
First Name & Middle Initial & Last Name & Degree
Ganessan Kichenadasse, MBBS, MD, FRACP
Facility Name
Monash Medical Centre
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Email
sophia.frentzas@monashhealth.org
First Name & Middle Initial & Last Name & Degree
Sophia Frentzas, MD
Facility Name
Cabrini Health
City
Malvern
ZIP/Postal Code
3144
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+61395096988
Email
gary.richardson@ocv.net.au
First Name & Middle Initial & Last Name & Degree
Gary Richardson, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Access Criteria
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.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/dbc0aa0e1b69463d?idFilter=%5B%22TAK-280-1501%22%5D
Description
To obtain more information on the study, click here/on this link

Learn more about this trial

First-in-Human Study of TAK-280 in Participants With Unresectable Locally Advanced or Metastatic Cancer

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