69 Participants Needed

TAK-280 for Advanced Cancer

Recruiting at 23 trial locations
TC
Overseen ByTakeda Contact
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Takeda
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The main aim of this study is to find out the safety, tolerability, and effect of TAK- 280 in participants with unresectable, locally advanced or metastatic cancer who have experienced treatment failure or are intolerant to standard therapies. Participants will be treated with TAK-280 for up to 14 treatment cycles. Each treatment cycle will be 28 days. After the last dose of study drug, participants will be followed up for survival every 12 weeks for a total of 48 weeks.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the treatment TAK-280 unique for advanced cancer?

TAK-280 is unique because it involves the use of gamma delta T-cells, which are a type of immune cell that can directly attack cancer cells and enhance the body's immune response against tumors. This approach is different from traditional cancer treatments as it leverages the body's own immune system to target and destroy cancer cells.12345

Research Team

SD

Study Director

Principal Investigator

Takeda

Eligibility Criteria

This trial is for adults with advanced or metastatic cancer who haven't responded to standard treatments or can't tolerate them. They should be relatively active (with a good performance status), have measurable disease, and not have had major surgery recently. People with known allergies to TAK-280, autoimmune diseases, recent live vaccines, ongoing infections, low oxygen levels without support, or unresolved wounds are excluded.

Inclusion Criteria

I am 18 years old or older.
My cancer is advanced, cannot be surgically removed, and has spread.
My cancer can be measured by scans, except if it's prostate cancer with only bone spread.
See 2 more

Exclusion Criteria

I haven't had live vaccines in 4 weeks or any vaccine in 2 weeks, except the flu shot.
History of known autoimmune disease
I do not have a serious or uncontrolled infection.
See 5 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Participants receive TAK-280 to determine the recommended doses for expansion

Up to 14 months
Visits on Days 1, 8, 15, and 22 of each 28-day cycle

Cohort-expansion

Participants receive TAK-280 at determined doses in 28-day cycles until disease progression or withdrawal

Up to 14 months
Visits on Days 1, 8, 15, and 22 of each 28-day cycle

Follow-up

Participants are monitored for survival every 12 weeks after the last dose

48 weeks

Treatment Details

Interventions

  • TAK-280
Trial OverviewThe study tests the safety and effects of a new cancer drug called TAK-280 over up to 14 cycles of treatment (each cycle lasts 28 days). The goal is to see how well participants tolerate this drug and what impact it has on their cancer when other treatments have failed.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Dose-escalation Phase: TAK-280Experimental Treatment1 Intervention
Participants will receive TAK-280 intravenous (IV) infusion on Days 1, 8, 15, and 22 of a 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.
Group II: Cohort-expansion Phase: TAK-280 High or low DoseExperimental Treatment1 Intervention
Participants will receive either TAK-280 high or low dose in one selected indication and only one dose level of TAK-280 in the remaining indications as determined from the dose-escalation phase of the study in 28-day treatment cycle until disease progression, unacceptable toxicity, or withdrawal from study occurs.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials
1,255
Recruited
4,219,000+
Dr. Naoyoshi Hirota profile image

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber profile image

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Takeda Development Center Americas, Inc.

Industry Sponsor

Trials
58
Recruited
10,800+

Findings from Research

In a phase I clinical study involving 18 patients with advanced solid tumors, the adoptive transfer of ex vivo expanded Vγ9Vδ2 T cells combined with zoledronate was found to be safe, with no dose-limiting toxicities reported.
While most patients did not show significant improvement, three patients experienced disease responses when Vγ9Vδ2 T cells were used alongside previously ineffective treatments, indicating potential for additive therapeutic effects.
Clinical evaluation of autologous gamma delta T cell-based immunotherapy for metastatic solid tumours.Nicol, AJ., Tokuyama, H., Mattarollo, SR., et al.[2021]
Human Vγ9Vδ2 T-cells, a type of immune cell, show strong potential in cancer treatment due to their ability to recognize and attack tumor cells, with a low toxicity profile observed in clinical studies.
While Vγ9Vδ2 T-cells have demonstrated modest therapeutic efficacy so far, ongoing research is focused on enhancing their anti-tumor functions through various strategies, including improving their recognition of cancer cells and boosting their cytotoxic activity.
Improving the Efficiency of Vγ9Vδ2 T-Cell Immunotherapy in Cancer.Hoeres, T., Smetak, M., Pretscher, D., et al.[2021]
The study developed a novel approach using SmartDC technology to activate T lymphocytes specifically targeting the folate receptor alpha (FRα), which is highly expressed in breast cancer cells.
Activated T lymphocytes demonstrated significant cytotoxicity against breast cancer cell lines, with up to 89.7% of cancer cells being lysed, indicating the potential effectiveness of this adoptive cell transfer method in treating FRα-expressing breast cancer.
Activation of cytotoxic T lymphocytes by self-differentiated myeloid-derived dendritic cells for killing breast cancer cells expressing folate receptor alpha protein.Luangwattananun, P., Chiraphapphaiboon, W., Thuwajit, C., et al.[2022]

References

Clinical evaluation of autologous gamma delta T cell-based immunotherapy for metastatic solid tumours. [2021]
Improving the Efficiency of Vγ9Vδ2 T-Cell Immunotherapy in Cancer. [2021]
Activation of cytotoxic T lymphocytes by self-differentiated myeloid-derived dendritic cells for killing breast cancer cells expressing folate receptor alpha protein. [2022]
Phase II study of E7777 in Japanese patients with relapsed/refractory peripheral and cutaneous T-cell lymphoma. [2021]
Accumulation of a recombinant immunotoxin in a tumor in vivo: fewer than 1000 molecules per cell are sufficient for complete responses. [2023]