First-in-Human Study of TAK-280 in Participants With Solid Tumors

PHASE1PHASE2RECRUITING

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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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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 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.
  • 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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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2022-04-22

    Primary completion: 2025-02-28

    Study completion finish: 2026-07-01

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE1

      PHASE2

    trial

    Trial ID

    NCT05220098

    Intervention or treatment

    DRUG: TAK-280

    Conditions

    • Unresectable Locally Advanced or Metastatic Cancer

    Find a site

    Closest Location:

    Monash Medical Centre

    Research sites nearby

    Select from list below to view details:

    • Monash Medical Centre

      Clayton, Not Specified, Australia

    • Chris O'Brien Lifehouse Hospital

      Camperdown, New South Wales, Australia

    • Southern Oncology Clinical Research Unit

      Bedford Park, Not Specified, Australia

    • Cabrini Health

      Malvern, Not Specified, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    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.
    DRUG: TAK-280
    • Participants will receive TAK-280 as IV infusion.
    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.
    DRUG: TAK-280
    • Participants will receive TAK-280 as IV infusion.

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    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.From start of the initial dose up to Cycle 1 Day 28
    Number of Participants With Treatment- emergent Adverse Events (TEAEs)Not SpecifiedUp to approximately 37 months

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Maximum Observed Plasma Concentration (Cmax) of TAK-280Cmax of TAK-280 will be reported.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)
    Area Under Plasma Concentration-Time Curve (AUC) of TAK- 280AUC of TAK-280 will be reported.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)
    Time to Reach Maximum Observed Plasma Concentration (tmax) of TAK-280tmax of TAK-280 will be reported.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)
    Terminal Disposition Phase Half-Life (t1/2) of TAK-280t1/2 of TAK-280 will be reported.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)
    Total Clearance (CL) of TAK-280CL of TAK-280 will be reported.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)
    Volume of Distribution at Steady State (Vss) After IV Administration of TAK-280Vss of TAK-280 will be reported.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)
    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.Up to approximately 37 months
    Duration of Response (DOR) Based on RECIST V1.1DOR 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).Up to approximately 37 months
    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.From start of first dose to disease progression or death, whichever occurred first (up to approximately 37 months)
    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.From start of first dose of study drug up to death (up to approximately 37 months)
    Disease Control RateDisease 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.Up to approximately 37 months
    Percentage of Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Having Prostate-Specific Antigen (PSA) ResponsePSA response is defined as PSA reduction from baseline of \>= 50 percent (%) and confirmed at least 3 weeks later.Up to approximately 37 months
    Duration of PSA Response in Participants With mCRPCDuration of PSA response is defined as the time from first PSA response to first documented PSA progression.Up to approximately 37 months
    Time to PSA Progression in Participants With mCRPCTime 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.Up to approximately 37 months
    Percentage of Participants With mCRPC Having PSA Reductions of >= 50% up to 6 MonthsNot SpecifiedBaseline up to 6 months
    Percentage of Participants who Develop Positive Induced Antidrug Antibody (ADA) for TAK-280Not SpecifiedCycle 1 to 5: pre-dose (Each cycle= 28 days)
    Percentage of Participants who Developed Neutralizing Antibody (NAb) Titers for TAK-280Not SpecifiedCycle 1 to 5: pre-dose (Each cycle= 28 days)

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    References

    Clinical Trials Gov: First-in-Human Study of TAK-280 in Participants With Solid Tumors

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