Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-505 · 1 trial · 1 indication
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.
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.
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)
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.
| Arm | Type | Description |
|---|---|---|
| Phase 1: TAK-505 Dose Escalation | EXPERIMENTAL | Participants will receive TAK-505 intravenous (IV) infusion until disease progression intolerability, or any other treatment discontinuation criterion is met. |
| Phase 2: TAK-505 Dose Expansion | EXPERIMENTAL | Participants with up to 3 selected tumor indications will receive the recommended dose for expansion (RDE) until disease progression intolerability, or any other treatment discontinuation criterion is met. |
| Name | Type | Description |
|---|---|---|
| TAK-505 | DRUG | Participants will receive TAK-505 intravenously (IV) |
Inclusion Criteria: 1. Aged greater than or equal to (≥) 18 years or ≥ the local legal age of majority, as applicable, at the time of signing the main informed consent form (ICF). 2. Criteria for disease state in dose escalation and cohort-expansion: 1. Tumor histologies during dose escalation ...
TAK-505 is an investigational small molecule being studied for the treatment of malignant solid tumors in adults. It is in Phase 1 clinical development and is not yet approved for any indication. The ongoing study enrolls adults 18 years and older with solid tumors.
TAK-505 is being developed by Takeda Pharmaceutical Company Limited, which trades on the New York Stock Exchange under the ticker TAK. Takeda is the sponsor of the clinical program evaluating the compound in oncology.
TAK-505 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory agency. The Phase 1 program is currently recruiting participants with malignant solid tumors.
TAK-505 is being evaluated in one clinical trial, NCT07436728, titled A Study of TAK-505 in Adults With Solid Tumors. The trial is a controlled Phase 1 study that is currently recruiting, with a planned enrollment of 151 participants across sites in the United States.
Yes. The TAK-505 Phase 1 trial NCT07436728 uses biomarker-based selection, meaning participants are enrolled based on specific biomarker criteria rather than an unselected solid tumor population. The study enrolls adults 18 years and older of any sex and does not include healthy volunteers.