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TAK-853

Phase 3

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

TAK-853 development status

Highest phase Phase 3 run by AbbVie (NCT04209855)
Phase scored for TAKPhase 1
Registered trials 8 across 2 sponsors since Dec 2019

TAK-853 target and mechanism

ModalitySmall molecule

Also known as Mirvetuximab Soravtansine

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

TAK-853 clinical trials

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 244 trials

Top 20 of 60 competitors

CompanyTickerTrialsLead PhaseDrugs
GSK plc Sponsored ADRGSK7PHASE3Niraparib, Dostarlimab, Mocertatug rezetecan
AstraZeneca PLCAZN21PHASE3Olaparib, Durvalumab, AZD5335, Torvutatug samrotecan, Datopotamab deruxtecan
Merck & Co., Inc.MRK16PHASE3Pembrolizumab, Sacituzumab tirumotecan, Raludotatug Deruxtecan, Patritumab Deruxtecan, MK-6255
Eli Lilly and CompanyLLY8PHASE3Sofetabart Mipitecan, Gemcitabine, Abemaciclib, LY4101174, LY3537982
AbbVie, Inc.ABBV14PHASE3Mirvetuximab soravtansine, Brimonidine eye, IMGN151, ABBV-400, ABBV-901
Bristol-Myers Squibb CompanyBMY4PHASE3Nivolumab, BMS-986340, Pumitamig, BMS-986463, BMS-986500
Genmab A/S Sponsored ADRGMAB7PHASE3Rina-S, GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells
Pfizer Inc.PFE4PHASE3Avelumab, Lorlatinib, Talazoparib, Axitinib, Utomilumab
Corcept Therapeutics Incorporated.CORT2PHASE3Relacorilant
Verastem, Inc.VSTM5PHASE3Avutometinib, Defactinib
Incyte CorporationINCY3PHASE3INCB123667
Zentalis Pharmaceuticals, Inc.ZNTL3PHASE3Azenosertib
Imunon, Inc.IMNN3PHASE3IMNN-001
Regeneron Pharmaceuticals, Inc.REGN5PHASE2Ubamatamab, Cemiplimab, Fianlimab, REGN10597, REGN5668
Novartis AG Sponsored ADRNVS5PHASE2Spartalizumab, Dabrafenib, trametinib, KFA115, Tulmimetostat
Genelux Corp.GNLX1PHASE3Olvimulogene nanivacirepvec
BeOne Medicines Ltd. Sponsored ADRONC3PHASE3Pamiparib, BG-C9074, BG-68501, BGB-43395
Xencor, Inc.XNCR3PHASE2vudalimab, XmAb541, XmAb808
Exelixis, Inc.EXEL2PHASE2Cabozantinib
Jazz Pharmaceuticals Public Limited CompanyJAZZ1PHASE2Zanidatamab
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Frequently asked questions about TAK-853

What is TAK-853 used for?

TAK-853 is an investigational small molecule being studied for the treatment of folate receptor alpha-positive advanced ovarian cancer and other solid tumors. It is a Phase 1 oncology candidate developed by Takeda Pharmaceutical Company Limited and is not yet approved for any indication.

Who is developing TAK-853?

TAK-853 is being developed by Takeda Pharmaceutical Company Limited, which trades on the New York Stock Exchange under the ticker TAK. The company is running the clinical program for this small molecule oncology candidate in Japan.

What phase is TAK-853 in?

TAK-853 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority. The single ongoing study is currently active but no longer recruiting participants.

What clinical trials is TAK-853 in?

TAK-853 is being evaluated in one clinical trial, NCT06390995, titled A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors. The Phase 1 study is active but not recruiting, is enrolling 28 participants, and is being conducted in Japan.

Is TAK-853 biomarker selected?

Yes. The Phase 1 trial for TAK-853 enrolls participants with folate receptor alpha-positive advanced ovarian cancer and other solid tumors, so enrollment is restricted to patients whose tumors express that biomarker. The study is uncontrolled, open-label, and accepts adults aged 18 years and older.