Trial · NCT07377045
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 38
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of participants with dose limiting toxicities (DLTs) during Part 1 of the study | At Day 1, Day 8 and Day 15 of the first 21-day cycle, and up to Day 1 of the second 21-day cycle. | The nature and frequency of DLTs will be assessed. |
| Primary | Number of participants with treatment emergent adverse events (TEAEs) during Part 1 of the study | From Screening visit through EoT visit (up to 90±5 days after the last dose of study treatment) | A TEAE is an AE that occurs from the first administration of the study drug up to EoT visit. They can be related to the study drug or not. Frequency, duration, and severity (per CTCAE v.5.0) of TEAEs will be assessed. |
| Primary | Changes in body temperature during Part 1 of the study | At Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). | Body temperature should be monitored during each infusion of OMTX705 as follows: on Cycle 1 and 2 before administration and every 30 (±5) minutes thereafter up to 1h ±5 minutes after the end of the infusion (EoI). From Cycle 3 onwards, it will be measured only at OMTX705 pre-dose and in case of clinical symptoms of an infusion-related reaction to document the AE. |
| Primary | Changes in blood pressure (BP) during Part 1 of the study | At Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). | BP will be measured in the sitting position after 5 minutes of rest. BP should be monitored during each infusion of OMTX705 as follows: on Cycle 1 and 2 before administration and every 30 (±5) minutes thereafter up to 1h ±5 minutes after the end of the infusion (EoI). From Cycle 3 onwards, it will be measured only at OMTX705 pre-dose and in case of clinical symptoms of an infusion-related reaction to document the AE. |
| Primary | Changes in pulse rate during Part 1 of the study | At Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). | Pulse rate will be measured in the sitting position after 5 minutes of rest. Pulse rate should be monitored during each infusion of OMTX705 as follows: on Cycle 1 and 2 before administration and every 30 (±5) minutes thereafter up to 1h ±5 minutes after the end of the infusion (EoI). From Cycle 3 onwards, it will be measured only at OMTX705 pre-dose and in case of clinical symptoms of an infusion-related reaction to document the AE. |
| Primary | Changes in electrocardiogram (ECG) PR interval during Part 1 of the study | At Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). | Changes in ECG assessed using a 12-lead ECG machine. In Cycle 1 and Cycle 2 ECGs will be recorded before the start of OMTX705 infusion and after the end of infusion (+15 minutes). |
| Primary | Changes in electrocardiogram (ECG) QRS interval during Part 1 of the study | At Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). | Changes in ECG assessed using a 12-lead ECG machine. In Cycle 1 and Cycle 2 ECGs will be recorded before the start of OMTX705 infusion and after the end of infusion (+15 minutes). |
| Primary | Changes in electrocardiogram (ECG) QT interval during Part 1 of the study | At Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). | Changes in ECG assessed using a 12-lead ECG machine. In Cycle 1 and Cycle 2 ECGs will be recorded before the start of OMTX705 infusion and after the end of infusion (+15 minutes). |
| Primary | Changes in electrocardiogram (ECG) Fridericia correction QT (QTcF) interval during Part 1 of the study | At Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). | Changes in ECG assessed using a 12-lead ECG machine. In Cycle 1 and Cycle 2 ECGs will be recorded before the start of OMTX705 infusion and after the end of infusion (+15 minutes). |
| Primary | Changes in concentration of serum chemistry parameters during Part 1 of the study | At Screening visit, at Day 1, Day 8 and Day 15 of the two first 21-day cycles, and at Day 1 and Day 8 of the subsequent 21-day cycles until treatment discontinuation (average of 4 months). | The following laboratory parameters will be measured for serum chemistry: albumin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (GGT), alkaline phosphatase (ALP), total bilirubin, calcium, creatinine, magnesium, potassium, sodium, lactate dehydrogenase, C-reactive protein, creatine phosphokinase and glucose. Chemistry C1D1 blood samples may be collected within 3 days before dosing to ensure participant eligibility. If screening clinical laboratory testing was performed within 3 days before the C1D1 dose, it does not need to be repeated. Chemistry blood samples will be obtained weekly for the first 2 cycles (Day 1, 8 and 15 of Cycle 1 and Cycle 2). From Cycle 3, chemistry will be collected only on the administration days (Day 1 and Day 8). Samples can be collected and analyzed the day before. |
| Primary | Changes in concentration of hematology parameters during Part 1 of the study | At Screening visit, at Day 1, Day 8 and Day 15 of the two first 21-day cycles, and at Day 1 and Day 8 of the subsequent 21-day cycles until treatment discontinuation (average of 4 months). | The following laboratory parameters will be measured for hematology: hemoglobin, platelet count, red blood cell count , white blood cells (WBC) count and differential WBC count (absolute number). Hematology C1D1 blood samples may be collected within 3 days before dosing to ensure participant eligibility. If screening clinical laboratory testing was performed within 3 days before the C1D1 dose, it does not need to be repeated. Hematology blood samples will be obtained weekly for the first 2 cycles (Day 1, 8 and 15 of Cycle 1 and Cycle 2). From Cycle 3, hematology will be collected only on the administration days (Day 1 and Day 8). Samples can be collected and analyzed the day before. |
| Primary | Treatment modifications during Part 1 of the study | From Screening visit and through the study until treatment discontinuation (average of 4 months). | Treatment modifications are measured as percentage of relative dose intensity. |
| Primary | Definition of Maximum tolerated dose (MTD) for Part 2 | From Screening visit and through the study until treatment discontinuation (average of 4 months). | MTD definition for Part 2: recommended dose will be based on MTD, or in absence of MTD based on non-DLT safety, efficacy as well as other relevant pharmacokinetics/pharmacodynamics evaluations. |
| Primary | Objective response rate (ORR) during Part 2 of the study | From Screening visit through EoT1 visit (30 ±2 days after the last dose of study treatment) | The ORR is defined as the proportion of participants who have a confirmed partial response (PR) or complete response (CR) to study treatment per RECIST v1.1 as determined by the investigator. |
| Secondary | Disease control rate (DCR) | From Screening visit through EoT1 visit (30 ±2 days after the last dose of study treatment). | DCR was assessed according to RECIST 1.1 criteria and defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD). |
| Secondary | Duration of response (DoR) | From Screening visit through EoT1 visit (30 ±2 days after the last dose of study treatment). | DoR following following RECIST 1.1 criteria. |
| Secondary | Time to response | From Screening visit through EoT1 visit (30 ±2 days after the last dose of study treatment) | Time to response following RECIST 1.1 criteria. |
| Secondary | Progression-free survival (PFS) | From Screening visit through the study until last PFS-FU visit (average of 4 months) | Time from enrollment to disease progression or death, whichever occurred first, assessed according to RECIST 1.1 criteria. Participants who discontinue study treatment for reasons other than progression disease (PD) will continue to attend progression-free survival follow-up (PFS-FU) visits every 12 (±1) weeks from the EoT1 visit until the occurrence of PD, loss to folow-up, consent withdrawal, death, the start of subsequent systemic antineoplastic therapy, or study termination, whichever occurs first. |
| Secondary | Proportion of participants without progression/death | At 3, 6 and 12 months | Percentage of participants who remained alive and free of disease progression according to RECIST 1.1 criteria at each timepoint |
| Secondary | Overall survival (OS) | From Screening visit through the study until last OS-FU visit (average of 4 months) | OS is defined as the time from enrollment to death from any cause. Participants' survival information (alive/dead and date of death) will be assessed every 3 months from the first dose of OMTX705 through participant contact (by phone or hospital visit) or at the time the death becomes known. If the site is aware that a patient is deceased, the date of death should be recorded in the eCRF without waiting for the next OS visit. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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