Study of TAK-280 in Patients With Advanced Cancer
Research type
Research Study
Full title
A Phase 1/2, First-in-Human, Open-Label, Dose-Escalation Study of TAK-280 in Patients With Unresectable Locally Advanced or Metastatic Cancer
IRAS ID
1008454
Contact name
Xin Ma
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc
Eudract number
2023-504012-16
Clinicaltrials.gov Identifier
Research summary
The main aim of this study is to find out the clinical safety, tolerability, and anti-tumour effect of the study drug TAK-280 in participants with certain types of cancer that cannot be cured by surgery removal or medication who do not respond to previous standard treatments or to whom the standard treatment is not available. Approximately 142 to 182 patients will take part in this study.
Participants will be treated with TAK-280 for up to 14 treatment cycles, each will last 28 days. After the last dose of study drug, participants will be checked on their condition every 12 weeks for a total of 48 weeks. This study consists of 2 phases. although the participants will only be required to take part in one of the two phases.
The dose escalation part includes participants whose cancer cells are likely to have a certain protein called B7-H3 on their surface. TAK-280 is designed to attach to the B7-H3 protein on the surface of tumours and activate the immune system to attack the tumours. Dose levels start from low at the beginning of the study and then increase in a step-by-step manner to find the highest dose that can be given safely, and the dose(s) that will be used in the dose expansion phase.
The dose expansion phase will include participants with only 3 types of cancer - metastatic castration-resistant prostate cancer, non-small-cell lung cancer, or cutaneous melanoma. Only participants with 1 type of cancer will receive either a higher dose or a lower dose of TAK-280. In the remaining 2 types of cancer to be studied in the dose-expansion phase, participants will receive only one dose level of TAK-280.REC name
South Central - Oxford C Research Ethics Committee
REC reference
23/SC/0410
Date of REC Opinion
5 Jan 2024
REC opinion
Further Information Favourable Opinion