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TAK-853

Phase 1

Ovarian Cancer | Small molecule | Oncology |Takeda Pharmaceutical Company Limited|Last Updated: Jun 16, 2026

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment28

FDA Designations

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Clinical trial landscape

TAK-853 · 1 trial · 2 indications

Phase 1 1
NCT06390995A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid TumorsOvarian Cancer
ACTIVE NOT_RECRUITING28 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors
Ovarian CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase 1: Number of Participants With Dose-Limiting Toxicities (DLTs) in Cycle 1
Up to Cycle 1 (up to 21 days)

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.

Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
From start of study drug up to 30 days after last dose (up to 3.7 months)

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.

Phase 1: Number of Participants With Grade 3 or Higher TEAEs by Severity
From start of study drug up to 30 days after last dose (up to 3.7 months)

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.

Phase 1: Number of Participants With Serious TEAEs
From start of study drug up to 30 days after last dose (up to 3.7 months)

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.

Phase 1: Number of Participants With TEAEs Leading to Drug Discontinuation
From start of study drug up to 30 days after last dose (up to 3.7 months)

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.

Phase 1: Number of Participants With TEAEs Leading to Infusion Interruption
From start of study drug up to 30 days after last dose (up to 3.7 months)

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.

Phase 1: Number of Participants With TEAEs Leading to Dose Delayed
From start of study drug up to 30 days after last dose (up to 3.7 months)

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.

Phase 1: Number of Participants With TEAEs Leading to Dose Reduction
From start of study drug up to 30 days after last dose (up to 3.7 months)

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.

Phase 1: Number of Participants With Adverse Event of Clinical Interest (AECIs)
From start of study drug up to 30 days after last dose (up to 3.7 months)

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.

Phase 2: Objective Response Rate (ORR) Assessed by Investigator With Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Up to 7.2 months

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).

Secondary Endpoints

Phase 1: Maximum Observed Plasma Concentration (Cmax) of TAK-853 and Total Antibody (TAb)
Cycle 1 and 3: pre-infusion, 2, 4, 6, 24, 48 hours post-infusion, and Days 4, 5, 8, and 15 post-infusion
Phase 1: Cmax of N2'-Deacetyl-N2'-(4-mercapto-4-methyl-1-oxopentyl)- Maytansine (DM4) and S-methyl DM4
Cycle 1 and 3: pre-infusion, 2, 4, 6, 24, 48 hours post-infusion, and Days 4, 5, 8, and 15 post-infusion
Phase 1: Area Under the Plasma Concentration-Time Curve Until Tlast (AUClast) and Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUCinf) of TAK-853 and TAb
Cycle 1 and 3: pre-infusion, 2, 4, 6, 24, 48 hours post-infusion, and Days 4, 5, 8, and 15 post-infusion
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1 Part and Phase 2 Part: TAK-853EXPERIMENTALTAK-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).

Interventions

NameTypeDescription
TAK-853DRUGTAK-853 intravenous injection
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

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...

Countries:Japan
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Competitive Landscape -Ovarian Cancer 176 trials

Top 20 of 59 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK5PHASE3Pembrolizumab, Paclitaxel, Bevacizumab, Docetaxel
AstraZeneca PLCAZN19PHASE3Olaparib
GSK plc Sponsored ADRGSK4PHASE3Niraparib
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Paclitaxel, Topotecan, Gemcitabine, Pegylated liposomal doxorubicin
AbbVie, Inc.ABBV13PHASE3Mirvetuximab soravtansine plus Bevacizumab, Bevacizumab
Bristol-Myers Squibb CompanyBMY4PHASE3Rucaparib, Nivolumab
Genmab A/S Sponsored ADRGMAB5PHASE3Rina-S, Paclitaxel, Topotecan, Pegylated liposomal doxorubicin, Gemcitabine
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatanib, Talazoparib, Pemetrexed, Axitinib
Corcept Therapeutics Incorporated.CORT2PHASE3Nab-paclitaxel/m^2, Relacorilant once daily
Verastem, Inc.VSTM4PHASE3avutometinib, Defactinib, Pegylated liposomal doxorubicin, Paclitaxel, Letrozole
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001, Paclitaxel, Carboplatin, Olaparib, Niraparib
Incyte CorporationINCY2PHASE3INCB123667
Genelux Corp.GNLX1PHASE3olvimulogene nanivacirepvec, Platinum chemotherapy: carboplatin or cisplatin, Non-platinum chemotherapy: Physician's Choice of gemcitabine, taxane or pegylated liposomal doxorubicin, Bevacizumab
Regeneron Pharmaceuticals, Inc.REGN4PHASE2Ubamatamab, Bevacizumab, Cemiplimab, Fianlimab, PLD
Novartis AG Sponsored ADRNVS4PHASE2Dabrafenib, Trametinib
BeOne Medicines Ltd. Sponsored ADRONC2PHASE3Pamiparib
IQVIA Holdings IncIQV1PHASE3Oregovomab, Paclitaxel, Carboplatin
Xencor, Inc.XNCR3PHASE2vudalimab
Exelixis, Inc.EXEL2PHASE2Cabozantinib
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Recent Changes (Last 90 Days)

LOWJun 16, 2026NCT06390995lastUpdatePostDate: changed
LOWJun 16, 2026NCT06390995lastUpdatePostDate: changed
LOWJun 16, 2026NCT06390995lastUpdatePostDate: changed

Frequently asked questions about TAK-853

What is TAK-853 used for?

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.

What does TAK-853 target?

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.

Who makes TAK-853?

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.

What phase is TAK-853 in?

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.

What clinical trials is TAK-853 in?

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.

Is TAK-853 the same as any other drug?

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.