Ignite Creation Date:
2024-05-06 @ 2:43 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04405778
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-27
First Post:
2020-05-26
Brief Title:
A Study of TAK-102 in Adult With Previously-Treated Solid Tumors
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Some solid tumors make a lot of a protein called glypican 3GPC3 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 persons 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 participants 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
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 participants 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 1 107 CAR cellsbody starting dose
Cohort 2 1 108 CAR cellsbody
Cohort 3 1 109 CAR cellsbody
In case Cohort 1 is not tolerable the dose level will be de-escalated to Cohort -1 3 106 CAR cellsbody Dose levels between planned cohorts andor 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
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 1 107 CAR cellsbody starting dose
Cohort 2 1 108 CAR cellsbody
Cohort 3 1 109 CAR cellsbody
In case Cohort 1 is not tolerable the dose level will be de-escalated to Cohort -1 3 106 CAR cellsbody Dose levels between planned cohorts andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1247-6429 | OTHER | None | None |
| jRCT1080225204 | REGISTRY | jRCT | None |