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

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ClinicalTrials.gov Identifier: NCT05220098
Recruitment Status : Recruiting
First Posted : February 2, 2022
Last Update Posted : May 6, 2022
Sponsor:
Collaborator:
Takeda Development Center Americas, Inc.
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE January 7, 2022
First Posted Date  ICMJE February 2, 2022
Last Update Posted Date May 6, 2022
Actual Study Start Date  ICMJE April 22, 2022
Estimated Primary Completion Date February 28, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2022)
  • Number of Participants With Treatment- emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 37 months ]
  • Recommended Phase 2 Dose (RP2D) of TAK-280 [ Time Frame: Up to approximately 37 months ]
    The RP2D is the maximum tolerated dose (MTD) or less.
  • Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: From start of the initial dose up to Cycle 1 Day 28 ]
    DLT evaluation period is defined as the time between the initial dose of TAK-280 and Cycle 1 Day 28.
  • Maximum Tolerated Dose (MTD) of TAK-280 [ Time Frame: Up to approximately 37 months ]
    MTD is selected as the dose for which the isotonic estimate of the toxicity rate is closest to the target toxicity rate of 30%.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2022)
  • Percentage of Participants With Confirmed Overall Response Rate (ORR) Based on Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (mRECIST 1.1) [ Time Frame: Up to approximately 37 months ]
  • Duration of Response (DOR) Based on mRECIST 1.1 [ Time Frame: Up to approximately 37 months ]
  • Progression Free Survival (PFS) [ Time Frame: From start of first dose to disease progression or death, whichever occurred first (up to approximately 37 months) ]
  • Overall Survival (OS) [ Time Frame: From start of first dose of study drug up to death (up to approximately 37 months) ]
  • Percentage of Participants With Prostrate Cancer (PC) Having Prostate-Specific Antigen (PSA) Reduction of >= 50% up to 6 Months [ Time Frame: Baseline up to 6 months ]
  • Maximum Observed Plasma Concentration (Cmax) of TAK-280 [ Time Frame: Cycle 1 Day 1: 0 (Pre-dose) to 48 hours, Day 8, 15: 0 to 6 hours, Day 22: 0 to 1 hour; Cycle 2 Day 1, 8, 15, 22: 0 to 1 hour; Cycle 3 Day 1: 0 to 4 hours; Day 8, 15, 22: 0 to 1 hour; Cycle 5 Day 1: 0 to 1 hour post-dose (Each cycle = 28 days) ]
    Cmax of TAK-280 will be reported.
  • Area Under Plasma Concentration-Time Curve (AUC) of TAK- 280 [ Time Frame: Cycle 1 Day 1: 0 (Pre-dose) to 48 hours, Day 8, 15: 0 to 6 hours, Day 22: 0 to 1 hour; Cycle 2 Day 1, 8, 15, 22: 0 to 1 hour; Cycle 3 Day 1: 0 to 4 hours; Day 8, 15, 22: 0 to 1 hour; Cycle 5 Day 1: 0 to 1 hour post-dose (Each cycle = 28 days) ]
    AUC of TAK-280 will be reported.
  • Time to Reach Maximum Observed Plasma Concentration (tmax) of TAK-280 [ Time Frame: Cycle 1 Day 1: 0 (Pre-dose) to 48 hours, Day 8, 15: 0 to 6 hours, Day 22: 0 to 1 hour; Cycle 2 Day 1, 8, 15, 22: 0 to 1 hour; Cycle 3 Day 1: 0 to 4 hours; Day 8, 15, 22: 0 to 1 hour; Cycle 5 Day 1: 0 to 1 hour post-dose (Each cycle = 28 days) ]
    tmax of TAK-280 will be reported.
  • Terminal Disposition Phase Half-Life (t1/2) of TAK-280 [ Time Frame: Cycle 1 Day 1: 0 (Pre-dose) to 48 hours, Day 8, 15: 0 to 6 hours, Day 22: 0 to 1 hour; Cycle 2 Day 1, 8, 15, 22: 0 to 1 hour; Cycle 3 Day 1: 0 to 4 hours; Day 8, 15, 22: 0 to 1 hour; Cycle 5 Day 1: 0 to 1 hour post-dose (Each cycle = 28 days) ]
    t1/2 of TAK-280 will be reported.
  • Total Clearance (CL) of TAK-280 [ Time Frame: Cycle 1 Day 1: 0 (Pre-dose) to 48 hours, Day 8, 15: 0 to 6 hours, Day 22: 0 to 1 hour; Cycle 2 Day 1, 8, 15, 22: 0 to 1 hour; Cycle 3 Day 1: 0 to 4 hours; Day 8, 15, 22: 0 to 1 hour; Cycle 5 Day 1: 0 to 1 hour post-dose (Each cycle = 28 days) ]
    CL of TAK-280 will be reported.
  • Volume of Distribution at Steady State After Intravenous Administration (Vss) of TAK-280 [ Time Frame: Cycle 1 Day 1: 0 (Pre-dose) to 48 hours, Day 8, 15: 0 to 6 hours, Day 22: 0 to 1 hour; Cycle 2 Day 1, 8, 15, 22: 0 to 1 hour; Cycle 3 Day 1: 0 to 4 hours; Day 8, 15, 22: 0 to 1 hour; Cycle 5 Day 1: 0 to 1 hour post-dose (Each cycle = 28 days) ]
    VSS of TAK-280 will be reported.
  • Percentage of Participants who Develop Cytokines for TAK-280 [ Time Frame: Cycle 1 to 5: pre-dose (Each cycle= 28 days) ]
    Percentage of participants who develop cytokines for TAK-280 will be reported.
  • 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) ]
    Percentage of participants who develop positive induced ADA for TAK-280 will be reported.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First-in-Human Study of TAK-280 in Participants With Unresectable Locally Advanced or Metastatic Cancer
Official Title  ICMJE A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer
Brief Summary

The main aim of this study is to find out the safety and tolerability of TAK- 280 in participants with unresectable, locally advanced or metastatic cancer failing or intolerant to standard therapies. The study consists of a dose-escalation phase to determine the recommended dose of TAK-280 for the cohort-expansion phase. Cohort-expansion phase will further define the safety and initial efficacy of TAK-280.

Participants will be treated with TAK-280 for up to 14 treatment cycles for a maximum total of 56 doses of TAK-280. Each treatment cycle will be 28 days. Participants will be treated with TAK- 280 until disease progression, unacceptable toxicity, or withdrawal from study occurs. Their cancer will be treated by their doctor according to their doctor's usual clinical practice.

After the last dose of study drug, participants will be followed up for survival every 12 weeks for at least 52 weeks.

Detailed Description

This study consists of 2 phases: Dose-escalation and cohort-expansion phase.

Dose-escalation phase:

Dose escalation will be conducted in participants with histologically proven, unresectable, locally advanced or metastatic cancers and the Bayesian Optimal Interval (BOIN) design will be used.

Cohort-Expansion Phase:

During the cohort-expansion phase, 5 separate participant cohorts will be enrolled, based on the tumor type. The dosing regimen used in the expansion cohorts will be the recommended phase 2 dose (RP2D) and schedule based on the safety, pharmacokinetics (PK), and antitumor activity findings from the dose-escalation phase of the study.

Enrollment into the expansion cohorts is based on a Simon 2-stage design.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Unresectable Locally Advanced or Metastatic Cancer
Intervention  ICMJE Drug: TAK-280
Participants will receive TAK-280 as IV infusion.
Study Arms  ICMJE Experimental: TAK-280
Participants will receive TAK-280 for up to 14 treatment cycles (Each treatment Cycle = 28 days) until disease progression, unacceptable toxicity, or withdrawal from study occurs.
Intervention: Drug: TAK-280
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 1, 2022)
186
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2026
Estimated Primary Completion Date February 28, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Takeda Contact +1-877-825-3327 medinfoUS@takeda.com
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05220098
Other Study ID Numbers  ICMJE TAK-280-1501
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
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.
URL: https://vivli.org/ourmember/takeda/
Current Responsible Party Takeda
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Takeda
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Takeda Development Center Americas, Inc.
Investigators  ICMJE
Study Director: Study Director Takeda
PRS Account Takeda
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP