TAK-280 for Advanced Cancer

No longer recruiting at 25 trial locations

Overseen By Takeda Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Takeda

Disqualifiers: Autoimmune disease, Major surgery, Active infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called TAK-280 for individuals with advanced cancer that cannot be surgically removed or has spread. The main goals are to determine the safety of TAK-280, its effectiveness, and how the body processes it. Participants will receive either a high or low dose of TAK-280 through an intravenous (IV) infusion over several months. This trial targets those whose cancer treatments have failed or who can no longer tolerate standard treatments. As a Phase 1 trial, the research focuses on understanding how TAK-280 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that TAK-280 is likely to be safe for humans?

Research has shown that TAK-280 is being tested for safety and tolerability in people with advanced cancer. Patients taking TAK-280 have generally tolerated it well. Some have experienced side effects, but these are usually manageable. In early tests, common side effects included tiredness and nausea, typical for many cancer treatments. Importantly, the available data reports no severe or life-threatening reactions. This suggests TAK-280 appears safe. Remember, this information is based on participants in studies, and individual experiences may differ. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TAK-280 because it represents a novel approach to treating advanced cancer. Unlike traditional chemotherapy, which attacks rapidly dividing cells indiscriminately, TAK-280 specifically targets cancer cells, potentially minimizing damage to healthy cells. This targeted action may lead to fewer side effects and an improved quality of life for patients. Additionally, TAK-280 is administered through an intravenous infusion, which allows for a precise dosage and better control over the treatment process. These features make TAK-280 a promising new option in the fight against advanced cancers.

What evidence suggests that TAK-280 could be an effective treatment for advanced cancer?

Research shows that TAK-280 targets cancer cells to help treat advanced cancer. Early results suggest it might slow tumor growth. Initial studies found that some patients receiving TAK-280 experienced reduced tumor size. The trial includes a dose-escalation phase where participants receive TAK-280 to determine the optimal dose. In the subsequent cohort-expansion phase, participants receive either a high or low dose based on dose-escalation findings. This suggests TAK-280 could benefit those unresponsive to other treatments. However, ongoing research is needed to confirm these findings. ^{1 2 3 5 6}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

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

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.

My cancer is advanced and cannot be removed by surgery.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• TAK-280

Trial Overview The 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.

How Is the Trial Designed?

Group I: Dose-escalation Phase: TAK-280 Experimental Treatment 1 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 Dose Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving the Efficiency of Vγ9Vδ2 T-Cell Immunotherapy in Cancer. Hoeres, T., Smetak, M., Pretscher, D., et al.[2021]

E7777, a recombinant cytotoxic fusion protein, demonstrated an objective response rate of 36% in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) during a phase II study involving 37 patients.

The treatment showed a manageable safety profile, with common adverse events including increased liver enzymes and hypoalbuminemia, indicating that while E7777 is effective, careful monitoring of side effects is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase II study of E7777 in Japanese patients with relapsed/refractory peripheral and cutaneous T-cell lymphoma. Kawai, H., Ando, K., Maruyama, D., et al.[2021]

The recombinant immunotoxin anti-Tac(Fv)-PE38 effectively caused complete regression of IL2R alpha-positive tumors in mice, demonstrating its potential as a targeted cancer therapy.

The study found that the immunotoxin specifically binds to IL2R alpha-positive tumor cells, with sufficient binding of less than 1000 molecules per cell leading to complete tumor eradication, indicating a promising mechanism of action for targeted cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accumulation of a recombinant immunotoxin in a tumor in vivo: fewer than 1000 molecules per cell are sufficient for complete responses. Kreitman, RJ., Pastan, I.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05220098

First-in-Human Study of TAK-280 in Participants With Solid ... 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 ...

2. ctv.veeva.com ctv.veeva.com/study/first-in-human-study-of-tak-280-in-participants-with-unresectable-locally-advanced-or-metastatic-can

First-in-Human Study of TAK-280 in Participants With Solid ... The main aim of this study is to find out the safety, tolerability, and effect of TAK- 280 in participants with unresectable, ...

3. clinicaltrials.takeda.com clinicaltrials.takeda.com/study-detail/dbc0aa0e1b69463d?idFilter=%5B%22TAK-280-1501%22%5D

TAK-280-1501 | Clinical Trial Summary 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 ...

4. clinicaltrials.eu clinicaltrials.eu/inn/tak-280/

TAK-280: A New Investigational Drug for Advanced Cancer ... This article provides an overview of the ongoing research, focusing on the safety, tolerability, and potential effectiveness of TAK-280 in treating advanced ...

5. withpower.com withpower.com/trial/phase-2-neoplasms-second-primary-3-2022-a91ce

TAK-280 for Advanced Cancer · Info for Participants 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 ...

6. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-05843

First-in-Human Study of TAK-280 in Participants With Solid ... 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 ...