TerminatedPhase 1

A Study of TAK-103 in Adult With Solid Tumors

Stopped: Business decision unrelated to patient safety

Japan2 participantsStarted 2022-01-05

Plain-language summary

In this study, people with mesothelin-expressing advanced or metastatic solid tumors will receive TAK-103 with their white blood cells. The main aims of this study are to check if the participants get any side effects from treatment with TAK-103 and to check how much TAK-103 participants can receive without getting side effects from it. Researchers can then work out the best dose of TAK-103 to give to participants in future studies. At the first visit, the study doctor will check who can take part. For those who can take part, the study doctors will collect white blood cells from each participant. These cells are sent to the laboratory where TAK-103 is added to each participant's cells. This can take up to 4 or 5 weeks. Participants may receive specific treatments while participants are waiting for TAK-103. Then, participants will receive TAK-103 with their cells slowly through a vein (infusion). Participants will receive lower to higher doses of TAK-103. Each participant will just receive 1 dose. The study doctors will check for side effects after each different dose of TAK-103. In this way, researchers can work out the best dose of TAK-103 to give to participants in future studies. Participants will stay in hospital for 28 days or longer for their treatment. Then, participants will visit the clinic for regular check-ups for up to 3 years.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Histologically or cytologically confirmed advanced or metastatic solid tumors who have no option with or are intolerant of standard therapies with a proven clinical benefit.
✓. Mesothelin-expression (\>=50% positive on viable tumor cells) must be determined on the tumor by immunohistochemistry using a validated assay, scoring and staining confirmed by the sponsor prior to leukapheresis procedures.
✓. Life expectancy \>=12 weeks.
✓. Eastern Cooperative Oncology Group performance status of 0 or 1.
✓. Adequate organ function as confirmed by clinical laboratory values as specified below:
✓. Total bilirubin =\<1.5 × the upper limit of the normal range (ULN) except in Participants with Gilbert's syndrome. Participants with Gilbert's syndrome may enroll with direct bilirubin =\<3 × ULN of the direct bilirubin. Elevated indirect bilirubin due to posttransfusion hemolysis is allowed
✓. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) must be \<3 × ULN.
✓. Calculated creatinine clearance \>50 mL/min (Cockcroft-Gault formula).

Exclusion criteria

What they're measuring

Percentage of Participants with Dose-Limiting Toxicities (DLTs)

Timeframe: Up to 28 days

Percentage of Participants With Treatment-emergent Adverse Event (TEAE)

Timeframe: Up to 1 years

Percentage of Participants With Adverse Events of Clinical Interest

Timeframe: Up to 1 years

Trial details

NCT IDNCT05164666

SponsorTakeda

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-22

View on ClinicalTrials.gov More Solid Tumors trials