A Study of TAK-505 in Adults With Solid Tumors

This study is testing a medicine called TAK-505 in adults who have solid tumors, which are lumps of cancer cells that can grow in organs like the lung or liver. This is the first time TAK-505 is being given to people, specifically those with certain types of cancer like stomach, colorectal, lung, and mouth cancer. The main goals are to see how safe TAK-505 is and what side effects it might cause, especially in the first 28 days of treatment. Researchers will also look at how many participants respond to the treatment over a longer period, up to about 52 months. You may be able to join if you are 18 years or older and have a solid tumor.

Study design: This is an interventional study with a planned enrollment of 151 participants. It will involve different phases, starting with finding the right dose and then expanding to see how well the treatment works.
What's involved: Participants will receive TAK-505 intravenously (through a vein). Safety will be monitored for at least 30 days after the last dose, and responses to treatment will be tracked for up to approximately 52 months.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for treatment-emergent adverse events and other safety measures for up to 30 days after their last dose. Their response to treatment will be monitored for up to approximately 52 months.

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A Study of TAK-505 in Adults With Solid Tumors

Recruiting

PHASE1Ages 18+InterventionalTreatment

Takeda

~151 participants

Updated 2026-05-14 on ClinicalTrials.gov

What's tested:TAK-505

At a glance

Recruiting sites

2 of 15 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Phase 1 Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)

Measured over From initial dose until 28 days after infusion of the first cohort dose on Cycle 1 Day 1

+3 more outcomes measured

Conditions

Malignant Solid Tumors

Where it's being run

15 sites across 9 states

Texas4

California3

Tennessee2

Florida1

Minnesota1

New York1

Ohio1

Virginia1

Study leadership

Study Director · STUDY_DIRECTOR · Takeda

Who to contact

Takeda Contact

[email protected]

+1-877-825-3327

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants with no known activating mutations: have received platinum-based chemotherapy and anti-programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) for locally advanced or metastatic disease (chemotherapy and anti-PD-1/PD-L1 treatment can be received in combination or in sequence).

Participants with a known activating mutation with an approved and accessible target therapy (including but not limited to epidermal growth factor receptor \[EGFR\], anaplastic lymphoma kinase, ROS proto-oncogene 1, receptor tyrosine kinase, v-raf murine sarcoma viral oncogene homolog B1V600, rearranged during transfection, mesenchymal epithelial transition \[MET\] exon 14 skipping mutation, neurotrophic tyrosine receptor kinase, and kirsten rat sarcoma G12C) should have received the respective targeted therapy and 1 line of platinum-based chemotherapy and anti-PD-1/PD-L1 (if appropriate).

Participants should have received no more than 3 prior lines of therapies for locally advanced or metastatic cancer.

Participants who have received or been intolerant to treatment with either trifluridine/tipiracil (TAS-102), regorafenib or fruquintinib. Participants who have been treated with all are permitted. Participants must also have been previously treated with standard approved therapies, such as: fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy, and, if rat sarcoma (RAS) wild-type, an anti-EGFR therapy or checkpoint inhibitors, as clinically appropriate.

Participants should have received no more than 4 prior lines of therapies for locally advanced or metastatic cancer.

Participants who have received or been intolerant to platinum/fluoropyrimidine doublet with or without anthracycline. Participants who are human epidermal growth factor receptor 2 (HER2) positive, PD-L1 positive or having microsatellite instability-high (MSI-H) should have received anti-HER2 and anti-PD-1/PD-L1 treatment, respectively.

Participants should have received no more than 3 prior lines of therapies for locally advanced or metastatic cancer.

What this trial measures

Phase 1 Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)From initial dose until 28 days after infusion of the first cohort dose on Cycle 1 Day 1
DLTs are defined as specific Grade 3 and 4 hematologic and hepatic nonhematologic events or any other Grade ≥3 adverse events related to treatment that occur during the DLT evaluation period after administration of TAK-505, except events that are clearly due to the underlying disease or an extraneous cause.
Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Clinically Significant Laboratory Values and Vital SignsFrom first dose of trial intervention through 30 days after administration of the last dose of trial intervention (up to approximately 52 months)
An Adverse Event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of TAK-505, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of TAK 505. TEAEs that occur after administration of the first dose of trial intervention and through 30 days after the last dose of trial intervention will be tabulated.
Phase 2 Dose Expansion: Confirmed Overall Response Rate (ORR)Up to end of study (up to approximately 52 months)
ORR is defined as the percentage of participants who achieve partial response (PR) or complete response (CR), as assessed by the investigator, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Phase 2 Dose Expansion: Number of Participants With TEAEs, Clinically Significant Laboratory Values and Vital SignsFrom first dose of trial intervention through 30 days after administration of the last dose of trial intervention (up to approximately 52 months)
An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of TAK-505, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of TAK 505. TEAEs that occur after administration of the first dose of trial intervention and through 30 days after the last dose of trial intervention will be tabulated.

Trialytics