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First-in-Human Study of TAK-280 in Participants With Solid Tumors
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.
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
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
TREATMENT
Phase
PHASE1
PHASE2
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
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/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Dose-escalation Phase: TAK-280
| DRUG: TAK-280
|
EXPERIMENTAL: Cohort-expansion Phase: TAK-280 High or low Dose
| DRUG: TAK-280
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary 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 Specified | Up to approximately 37 months |
Secondary outcome
| Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of TAK-280 | Cmax 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- 280 | AUC 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-280 | tmax 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-280 | t1/2 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-280 | CL 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-280 | Vss 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 V1.1 | 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). | 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 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. | Up to approximately 37 months |
| 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. | Up to approximately 37 months |
| 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. | Up to approximately 37 months |
| 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. | Up to approximately 37 months |
| Percentage of Participants With mCRPC Having PSA Reductions of >= 50% up to 6 Months | Not Specified | Baseline up to 6 months |
| Percentage of Participants who Develop Positive Induced Antidrug Antibody (ADA) for TAK-280 | Not Specified | Cycle 1 to 5: pre-dose (Each cycle= 28 days) |
| Percentage of Participants who Developed Neutralizing Antibody (NAb) Titers for TAK-280 | Not Specified | Cycle 1 to 5: pre-dose (Each cycle= 28 days) |
Frequently Asked Questions
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