TAK-280-1501

Recruiting

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

Clinicaltrials.gov

#NCT05220098

|

EU CTIS

#2023-504012-16-00

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.

US

ES

AU

1+

Interventional Phase 1/Phase 2 clinical trial.

What medical conditions are being studied?

Unresectable Locally Advanced or Metastatic Cancer

What is the clinical trial testing?

TAK-280

How many participants are being enrolled?

182

Are placebos part of the clinical trial?

No

When is the clinical trial being conducted?

Apr 2022 - Jul 2026

How long is participation in the clinical trial?

Participants will be in the study for about 37 months.

Sexes

All

Age

18+ Years

Healthy volunteers?

No

Must be women and men 18 years or older.

Must have unresectable, locally advanced or metastatic cancers.

Must be either ineligible or intolerant of standard therapies, have no approved therapy with demonstrated benefit available, or have exhausted all available standard therapies.

Cannot have history of known autoimmune disease (with some exceptions).

Cannot have major surgery or traumatic injury within 8 weeks before the first dose of TAK-280.

Additional entry criteria will be discussed with the study doctor.

Primary outcome measures

Number of Participants With Dose Limiting Toxicities (DLTs) [Time Frame: From start of the initial dose up to Cycle 1 Day 28]

Number of Participants With Treatment- emergent Adverse Events (TEAEs) [Time Frame: Up to approximately 37 months]

Secondary outcome measures

Maximum Observed Plasma Concentration (Cmax) of TAK-280 [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)]

Area Under Plasma Concentration-Time Curve (AUC) of TAK- 280 [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)]

Time to Reach Maximum Observed Plasma Concentration (tmax) of TAK-280 [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)]

Terminal Disposition Phase Half-Life (t1/2) of TAK-280 [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)]

Total Clearance (CL) of TAK-280 [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)]

Volume of Distribution at Steady State (Vss) After IV Administration of TAK-280 [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)]

Confirmed Overall Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1) [Time Frame: Up to approximately 37 months]

Duration of Response (DOR) Based on RECIST V1.1 [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)]

Disease Control Rate [Time Frame: Up to approximately 37 months]

Percentage of Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Having Prostate-Specific Antigen (PSA) Response [Time Frame: Up to approximately 37 months]

Duration of PSA Response in Participants With mCRPC [Time Frame: Up to approximately 37 months]

Time to PSA Progression in Participants With mCRPC [Time Frame: Up to approximately 37 months]

Percentage of Participants With mCRPC Having PSA Reductions of >= 50% up to 6 Months [Time Frame: Baseline up to 6 months]

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 Developed Neutralizing Antibody (NAb) Titers for TAK-280 [Time Frame: Cycle 1 to 5: pre-dose (Each cycle= 28 days)]