A Study of TAK-102 in Adult With Previously-Treated Solid Tumors

Summary

Participation Requirements

Description

The drug being tested in this study is called TAK-102. TAK-102 is being tested to treat people who have GPC3-expressing previously treated solid tumors. This study will look at the safety and tolerability of TAK-102 and will determine the RP2D of TAK-102. The study will enroll approximately 14 parti...

The drug being tested in this study is called TAK-102. TAK-102 is being tested to treat people who have GPC3-expressing previously treated solid tumors. This study will look at the safety and tolerability of TAK-102 and will determine the RP2D of TAK-102. The study will enroll approximately 14 participants, with a maximum of 18 participants. Participants will be assigned to 1 of the 3 treatment groups (dose cohorts) and dose escalation will be conducted in this study: Cohort 1: 1 × 10^7 CAR (+) cells/body [starting dose]. Cohort 2: 1 × 10^8 CAR (+) cells/body. Cohort 3: 1 × 10^9 CAR (+) cells/body. In case Cohort 1 is not tolerable, the dose level will be de-escalated to Cohort -1: 3 × 10^6 CAR (+) cells/body. Dose level(s) between planned cohorts and/or other dosing schedules may also be tested. This study consists of the Screening, Pretreatment, and Treatment and Primary Follow-up phases. In Treatment and Primary Follow-up phases, all participants will be asked to receive a single intravenous infusion of TAK-102 and administration of TAK-102 will continue up to Month 12. This multi-center trial will be conducted in Japan. The overall time to participate in this study is 15 years as a maximum including planned long-term follow-up study (the 12-month Treatment and Primary Follow-up and the 14-year Secondary Follow-up phases in another study). Participants will make multiple visits to the clinic and be hospitalized for at least 28 days to receive treatment with TAK-102 followed by a recovery period.

Tracking Information