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 developed for the treatment of malignant solid tumors. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in humans.
TAK-505 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda is listed on the stock exchange under the ticker symbol TAK. The company is conducting clinical trials to evaluate the safety and effectiveness of this investigational drug.
TAK-505 is currently in Phase 1 clinical development. This is the earliest stage of human testing, focused on evaluating the drug's safety, tolerability, and pharmacokinetics in patients with malignant solid tumors. The drug is investigational and has not yet received regulatory approval.
TAK-505 is being studied in a Phase 1 clinical trial with the identifier NCT07436728, titled 'A Study of TAK-505 in Adults With Solid Tumors.' This trial is currently recruiting participants in the United States and aims to enroll approximately 151 adults aged 18 years and older with malignant solid tumors.
TAK-505 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The ongoing study, NCT07436728, is evaluating the drug's safety and tolerability in adults with malignant solid tumors. Regulatory approval would require successful completion of further clinical trials and review by health authorities.