151 Participants NeededMy employer runs this trial

TAK-505 for Cancer

Recruiting at 14 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, TAK-505, to determine its safety and effectiveness for individuals with certain advanced solid tumors, such as lung, stomach, bowel, or head and neck cancers. Researchers aim to identify the optimal dose that minimizes side effects and to understand how the treatment behaves in the body. The trial seeks participants who have these cancers and have not found success with other treatments. As a Phase 1 trial, the research focuses on understanding how the treatment 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 protocol does not specify if you must stop taking your current medications. However, it mentions that certain therapies should not be received within specific time frames before starting the trial, such as cytotoxic chemotherapy within 2 weeks or monoclonal antibodies within 4 weeks. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that TAK-505 is likely to be safe for humans?

Research shows that TAK-505 is a new cancer drug tested on adults with solid tumors. The study aims to determine its safety and patient tolerance. Since TAK-505 is being administered to humans for the first time, information on its safety is limited. However, early studies are designed to carefully monitor for side effects. These initial studies typically involve administering lower doses to find the best balance between effectiveness and minimal side effects.

The process will closely monitor for any unwanted side effects to ensure patient safety. As TAK-505 is still in the early testing phases, safety information is still being collected. Participants will be under close supervision to quickly address any issues, helping to build a clearer understanding of TAK-505's safety profile.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about TAK-505 for cancer because it offers a novel approach compared to the standard treatments like chemotherapy and targeted therapies. Unlike these treatments, which generally attack cancer cells directly or target specific proteins in cancer cells, TAK-505 is unique in its mechanism of action. It potentially modulates the tumor microenvironment, which could make it more effective in fighting different types of tumors. Additionally, TAK-505 is administered via intravenous infusion, allowing for precise delivery and potentially reducing side effects associated with oral medications. This could lead to improved outcomes for patients who have not responded well to existing therapies.

What evidence suggests that TAK-505 might be an effective treatment for solid tumors?

Researchers are investigating TAK-505 as a new treatment for various solid tumors, including those in the stomach, colon, lungs, and head and neck. This trial consists of two phases: a dose escalation phase and a dose expansion phase. The aim is to determine if TAK-505 can shrink or slow these cancers. While direct information on TAK-505's efficacy remains limited, early signs suggest it might inhibit cancer cell growth. The goal is to assess its effectiveness with manageable side effects. As further studies progress, clearer evidence of its potential benefits is anticipated.12356

Who Is on the Research Team?

SD

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

This trial is for adults (18+) with certain advanced or metastatic solid tumors—specifically stomach, colorectal, lung (non-small cell), or head and neck cancers—who have already tried standard treatments but their cancer has not responded or has come back.

Inclusion Criteria

I have tried targeted therapy, platinum chemo, and immunotherapy for my cancer mutation.
I have had three or fewer treatments for advanced or metastatic cancer.
I have colorectal adenocarcinoma.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks
1 visit (in-person)

Phase 1: Dose Escalation

Participants receive TAK-505 intravenous infusion until disease progression or intolerability

Up to 7 months
Multiple visits per cycle (in-person)

Phase 2: Dose Expansion

Participants receive the recommended dose for expansion until disease progression or intolerability

Up to 9 months
Multiple visits per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • TAK-505

Trial Overview

The study is testing TAK-505, a new medicine being given to people for the first time. The main goals are to find out how safe it is, what dose works best with the fewest side effects, and if it can help shrink or slow down these types of cancers.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Phase 2: TAK-505 Dose ExpansionExperimental Treatment1 Intervention
Group II: Phase 1: TAK-505 Dose EscalationExperimental Treatment1 Intervention

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

Citations

A Study of TAK-505 in Adults With Solid Tumors

The main aims of this study are to learn how safe TAK-505 is, how well it works, how well adults with solid tumors tolerate it and to find the dose of TAK-505 ...

Takeda's TAK-505 Trial Marks a New Bet on Difficult Solid ...

For investors, this early TAK-505 update signals Takeda's push deeper into oncology and high-risk, high-reward tumor indications, which could ...

A Study of TAK-505 in Adults With Solid Tumors

The main aims of this study are to learn how safe TAK-505 is, how well it works, how well adults with solid tumors tolerate it and to find the ...

TAK-505 for Cancer · Recruiting Participants for Phase ...

This Phase 1 & 2 medical study run by Takeda is evaluating whether TAK-505 will have tolerable side effects & efficacy for patients with Cancer.

TAK-505 - Drug Targets, Indications, Patents

Clinical Results associated with TAK-505. Login to view more data. 100 Translational Medicine associated with TAK-505. Login to view more data.

TAK-500-1001 | Clinical Trial Summary

This study is about TAK-500, given either alone or with pembrolizumab, in adults with select locally advanced or metastatic solid tumors.