Trial · NCT06390995
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| 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). |
| Secondary | 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 | Pharmacokinetic (PK) parameters were calculated using standard non-compartmental methods. Cmax of TAK-853 and TAb were reported at cycle 1 and cycle 3. |
| Secondary | 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 | PK parameters were calculated using standard non-compartmental methods. Cmax of DM4 and S-methyl DM4 were reported at cycle 1 and cycle 3. |
| Secondary | 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 | PK parameters were calculated using standard non-compartmental methods. AUClast and AUCinf of TAK-853 and TAb were reported at cycle 1 and cycle 3. |
| Secondary | Phase 1: AUClast and AUCinf of 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 | PK parameters were calculated using standard non-compartmental methods. AUClast and AUCinf of DM4 and S-methyl DM4 were reported at cycle 1 and cycle 3. |
| Secondary | Phase 1: Terminal Half-Life (t1/2) of TAK-853, TAb, 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 | PK parameters were calculated using standard non-compartmental methods. t1/2 of TAK-853, TAb, DM4 and S-methyl DM4 were reported at cycle 1 and cycle 3. |
| Secondary | Phase 1: Total Clearance (CL) 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 | PK parameters were calculated using standard non-compartmental methods. CL of TAK-853 and TAb were reported at cycle 1 and cycle 3. |
| Secondary | Phase 1: Apparent Clearance (CL/F) of 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 | PK parameters were calculated using standard non-compartmental methods. CL/F of DM4 and S-methyl DM4 were reported at cycle 1 and cycle 3. |
| Secondary | Phase 1: Volume of Distribution at Steady State (Vss) of TAK-853, TAb and Apparent Volume of Distribution During the Terminal Phase (VZ/F) of 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 | PK parameters were calculated using standard non-compartmental methods. Vss of TAK-853, TAb and VZ/F of DM4 and S-methyl DM4 were reported at cycle 1 and cycle 3. |
| Secondary | Number of Participants With Immunogenicity of TAK-853 | From start of study drug up to 8.2 months | Blood samples were collected to measure the presence of TAK-853 antibodies (ADA). Seronegative was defined as a participant with negative ADA at baseline and negative ADA at post-treatment. Treatment-emergent ADA was defined as a participant with negative ADA at baseline and positive ADA at post-treatment. Treatment-unaffected ADA was defined as a participant with positive ADA at baseline and post-dose titer increase that was less than or equal to 4-fold compared to baseline. Treatment-enhanced ADA was defined as a participant with positive ADA at baseline and post-dose titer increase that was greater than 4-fold compared to baseline. |
| Secondary | Phase 2: Duration of Response (DOR) Assessed by Investigator With RECIST 1.1 | From first documented confirmed CR or PR until first documentation of PD (up to 7.2 months) | DOR was defined as the time from the first observation of CR/PR (whichever is first recorded) to the first date at which progressive disease is objectively documented per RECIST 1.1, or death due to any cause, whichever occurs first. DOR was estimated using the Kaplan-Meier method. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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