Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TAK-853 · 1 trial · 2 indications
DLT was evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) V5.0 and defined as any of following events: 1. If re-treatment was not initiated within 14 days due to adverse event (AE) related to protocol treatment; 2. Grade 4 neutropenia for more than 7 days; 3. Grade 3 or 4 neutropenia with single temperature reading \>= 38.3-degree Celsius (°C) or sustained temperature reading of greater than (\>) 38°C for \>1 hour; 4. Platelet counts decreased of Grade 3 requiring platelet transfusion or blood platelet decreased of Grade 4; 5. Grade 3 or higher non-hematologic toxicity that was considered clinically significant, except following cases, AEs related to underlying disease, Alopecia, Grade 3 fatigue, Lymphopenia unless accompanied by clinically significant infection, isolated and asymptomatic Grade 3 abnormalities in biochemistry laboratory values that last for less than and equal to (\<=) 7 days including electrolyte abnormalities.
An AE means any untoward medical occurrence in a participant administered a pharmaceutical product; the untoward medical occurrence does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product whether or not it is related to the medicinal product. This includes any newly occurring event, or a previous condition that has increased in severity or frequency since the administration of study drug.
The severity grade was evaluated as per the NCI CTCAE Version 5.0, where Grade 1 scales as Mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 scales as Moderate (minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living \[ADL\]); Grade 3 was severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living (ADL), Grade 4 was life-threatening consequences; urgent intervention indicated, and Grade 5 was death related to AE. TEAEs were AEs with an onset date on or after the first dose of study drug, and within 30 days of the last dose of study drug or prior to the start of a new anti-cancer treatment, whichever occurs first.
A serious TEAE is any untoward medical occurrence or effect that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, and was an important medical event.
TEAEs were defined as AEs with an onset date on or after the first dose of study drug, and within 30 days of the last dose of study drug or prior to the start of a new anti-cancer treatment, whichever occurred first. Number of participants with TEAEs leading to study drug discontinuation were reported.
TEAEs were defined as AEs with an onset date on or after the first dose of study drug, and within 30 days of the last dose of study drug or prior to the start of a new anti-cancer treatment, whichever occurred first. Number of participants with TEAEs leading to infusion interruption were reported.
TEAEs were defined as AEs with an onset date on or after the first dose of study drug, and within 30 days of the last dose of study drug or prior to the start of a new anti-cancer treatment, whichever occurred first. Number of participants with TEAEs leading to dose delayed were reported.
TEAEs were defined as AEs with an onset date on or after the first dose of study drug, and within 30 days of the last dose of study drug or prior to the start of a new anti-cancer treatment, whichever occurred first. Number of participants with TEAEs leading to dose reduction were reported.
AECIs (serious or nonserious) were those TEAEs which were of scientific and medical concern specific to the TAK-853. AECIs for TAK-853 included: 1. Ocular TEAEs, 2. Pneumonitis TEAEs, 3. Peripheral neuropathy TEAEs and 4. Infusion related TEAEs.
ORR was defined as the percentage of participants who achieved a confirmed Partial Response (PR) or confirmed Complete Response (CR) during the study using RECIST 1.1. Complete response (CR): Disappearance of all target lesions. All pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 millimeters (mm). Partial response (PR): At least a 30% decrease in the sum of diameters (SoD of target lesions, taking as reference the baseline SoD).
| Arm | Type | Description |
|---|---|---|
| Phase 1 Part and Phase 2 Part: TAK-853 | EXPERIMENTAL | TAK-853, 6.0 mg/kg, injection, intravenously (IV), once every 3 weeks. Patients will continue to receive study drug until disease progression, unacceptable toxicity, withdrawal of consent, death, or until the sponsor terminates the study (whichever comes first). |
| Name | Type | Description |
|---|---|---|
| TAK-853 | DRUG | TAK-853 intravenous injection |
Inclusion Criteria: Phase 1 part: 1. Diagnosis, allowable prior therapy, and disease measurability requirements: 1. All participants must have a pathologically documented, following advanced solid tumor known to express folate receptor alpha (FR alpha), that is resistant or refractory to stand...
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TAK-853 is an investigational small molecule being developed for the treatment of ovarian cancer, specifically folate receptor alpha-positive advanced ovarian cancer, as well as other solid tumors. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
TAK-853 targets folate receptor alpha, a protein that is often overexpressed in certain cancers, including ovarian cancer. By targeting this receptor, the drug aims to deliver its therapeutic effect to cancer cells that express this marker, potentially offering a targeted treatment approach for patients with advanced disease.
TAK-853 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company headquartered in Japan. Takeda is listed on the stock exchange under the ticker symbol TAK, and the company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
TAK-853 is currently in Phase 1 clinical development. This early-stage trial is designed to assess the safety, tolerability, and preliminary efficacy of the drug in adult participants with folate receptor alpha-positive advanced ovarian cancer and other solid tumors. The drug is investigational and has not yet received regulatory approval.
TAK-853 is being studied in a Phase 1 clinical trial registered as NCT06390995. This open-label, uncontrolled study is enrolling approximately 28 adult participants in Japan with folate receptor alpha-positive advanced ovarian cancer and other solid tumors. The trial is currently active but not recruiting participants.
TAK-853 is a unique investigational compound developed by Takeda Pharmaceutical Company Limited. There are no alternative names provided for this drug in the available information. It is being studied specifically for its potential role in treating folate receptor alpha-positive cancers, including ovarian cancer.