Trial · NCT06390995
A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors
NCT06390995, Phase 1, Phase 2, Active not recruiting, Takeda
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors. Trials, record NCT06390995. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06390995
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of TAK-853 in Adult Participants With Folate Receptor Alpha-Positive Advanced Ovarian Cancer And Other Solid Tumors
- NCT number
- NCT06390995
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Ovarian Cancer, Solid Tumors
- Interventions
- TAK-853
- First posted
- 2024-04-30
- Last updated
- 2026-06-16
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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). |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06390995
GET https://conductscience.org/api/trials/v1/NCT06390995/registered?page=2