CP-MVC-101-01

Recruiting

A Study of TAK-186 (Also Known as MVC-101) in Adults With Advanced or Metastatic Cancer

Clinicaltrials.gov

The main aim of this study is to check for side effects and tolerability of TAK-186 (also known as MVC-101) in adults with unremovable advanced or metastatic cancer. Another aim is to characterize and evaluate the activity of TAK-186 (MVC-101). Participants may receive treatment throughout the study for a maximum of 13 months and will be followed up at 30 days and 90 days and then every 12 weeks for up to 48 weeks after the last treatment.

US

AU

KR

1+

Interventional Phase 1/Phase 2 clinical trial.

What medical conditions are being studied?

Colorectal Cancer

Non-small Cell Lung Cancer (NSCLC)

Squamous Cell Cancer of Head and Neck (SCCHN)

What is the clinical trial testing?

TAK-186

How many participants are being enrolled?

258

Are placebos part of the clinical trial?

No

When is the clinical trial being conducted?

Mar 2021 - Nov 2026

How long is participation in the clinical trial?

Participants may stay in the study as long as they are receiving benefits from the treatment (for a maximum of 7 treatment cycles) or until the study ends (up to 1 year of follow-up after the last treatment).

Sexes

All

Age

18+ Years

Healthy volunteers?

No

Both men and women can take part.

Must be adults 18 years or older.

Must have diagnosis of unremovable advanced or metastatic cancer.

Must be intolerant to standard therapy or standard therapy must have failed.

Cannot have another serious medical condition.

Additional entry criteria will be discussed with the study doctor.

Primary outcome measures

Number of Participants with Treatment Emergent Adverse Events (TEAEs) [Time Frame: From the signing of ICF through 30 days after the last dose of study drug for non immune-related AEs, and through 90 days after the last dose of study drug for immune-related AEs (Up to approximately 13 months)]

Number of Participants with Cytokine Release Syndrome/Infusion Reactions [Time Frame: From the signing of ICF through 30 days after the last dose of study drug (Up to approximately 13 months)]

Number of Participants with a Dose-Limiting Toxicity (DLT) [Time Frame: DLT Evaluation Period (up to Day 28) in Dose Escalation Phase]

Secondary outcome measures

Recommended Phase 2 Dose (RP2D) [Time Frame: Up to approximately 13 months]

Cmax: Maximum Observed Plasma Concentration of TAK-186 [Time Frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)]

Tmax: Time of First Occurrence of Maximum Observed Plasma Concentration (Cmax) of TAK-186 [Time Frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)]

AUCtau: Area Under the Plasma Concentration-time Curve for a Dosing Interval for TAK-186 [Time Frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)]

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Last Quantifiable Concentration for TAK-186 [Time Frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)]

AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-186 [Time Frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)]

Ctrough: Trough Plasma Concentration of TAK-186 [Time Frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)]

CL: Clearance of TAK-186 [Time Frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)]

Vss: Volume of Distribution at Steady State for TAK-186 [Time Frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)]

t1/2: Terminal Half-Life of TAK-186 [Time Frame: Pre-dose and at multiple time points post-dose on Days 1, 2, 8, 9, 10, 15, 22, 29, 36, 43, 50 up to end of treatment (Up to 13 months)]

Number of Participants with Anti-drug Antibodies (ADA) in Plasma for TAK-186 [Time Frame: Up to approximately 13 months]

Preliminary Anti-tumor Activity of TAK-186 in Participants with Advanced Cancer Based on Tumor Protein Marker Changes in Serum [Time Frame: Up to approximately 13 months]

Objective Response Rate (ORR) [Time Frame: Up to approximately 13 months]

Duration of Response [Time Frame: Up to approximately 13 months]

Progression-free Survival (PFS) [Time Frame: Up to approximately 13 months]

Overall Survival (OS) [Time Frame: Up to approximately 13 months]