NCT04405778

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

An Open-Label, Dose Escalation, Phase 1, First-in-Human Study of TAK-102 in Adult Patients With GPC3-Expressing Previously Treated Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Some solid tumors make a lot of a protein called glypican 3(GPC3), which helps it to grow. Healthy cells and tissues do not make GPC3. TAK-102 is a medicine that sticks to GCP3 and stops it from working. It is hoped that TAK-102 will eventually treat people with solid tumors with the GPC3 protein. TAK-102 will be added to each person's white blood cells so is custom-made for each person. In this study, people with solid tumors with GPC3 will receive TAK-102 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-102 and to check how much TAK-102 they can receive without getting side effects from it. Researchers can then work out the best dose of TAK-102 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-102 is added to each participant's cells. This can take up to 4 weeks. Participants will receive specific treatments while they are waiting for TAK-102. Then, participants will receive TAK-102 with their cells slowly through a vein (infusion). 3 different small groups of participants will receive lower to higher doses of TAK-102. Each participant will just receive 1 dose. The study doctors will check for side effects after each different dose of TAK 102. In this way, researchers can work out the best dose of TAK-102 to give to participants in future studies. Participants will stay in hospital for 28 days or longer for their treatment. Then, they will visit the clinic for regular check-ups for up to 36 months.

Detailed 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 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 up to 15 years (In general, the 12-month Treatment and Primary Follow-up, 2-year Secondary Follow-up and then 12-year Long Term 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.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	TAK-102	TAK-102 intravenous infusion

Timeline

• Start date: 2020-07-10
• Primary completion: 2025-05-09
• Completion: 2025-05-09
• First posted: 2020-05-28
• Last updated: 2025-05-29

Locations

3 sites across 1 country: Japan