Trial · NCT07377045
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 38 of 38
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Proportion of participants alive | At 3, 6, 12 and 18 months | Percentage of participants alive at each timepoint |
| Secondary | Percentage of reduction in cancer antigen 19-9 (CA19-9) from baseline upon treatment | Part 1 and 2 (Arm 2A/2B): Screening and Day 1 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). Part 2 (Arm 2C): Screening and Day 1 of each 28-day cycle until treatment discontinuation (average of 4 months). | Changes in CA19-9 concentration from baseline upon treatment. CA19-9 will be measured locally in all participants at Screening and Day 1 of every cycle. |
| Secondary | Quantification (titer) of anti-drug antibodies (ADAs) against OMTX705 | Part 1 and 2 (Arm 2A/2B): At Day 1 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). | The formation of ADAs against OMTX705 will be assessed in blood samples collected prior to OMTX705 administration at Day 1 of each cycle, EoT1 and PFS-FU. The ADAs will be measured in a central laboratory designated by the sponsor. ADAs will not be assessed in Arm 2C. |
| Secondary | Percentage of ADA-positive participants | Part 1 and 2 (Arm 2A/2B): At Day 1 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). | Percentage of participants who develop detectable ADAs to OMTX705. The formation of ADAs against OMTX705 will be assessed in blood samples collected prior to OMTX705 administration at Day 1 of each cycle, EoT1 and PFS-FU. The ADAs will be measured in a central laboratory designated by the sponsor. ADAs will not be assessed in Arm 2C. |
| Secondary | Blood concentrations of conjugated antibody | Part 1 and 2 (Arm 2A/2B): At Day 1, Day 8 and Day 15 of Cycle 1, and at Day 1 and Day 8 of Cycle 2 and Cycle 4 (each cycle is 21 days). | Blood concentrations of conjugated antibody will be listed and summarized using descriptive statistics. The measurement of conjugated antibody will be performed using validated methods at a central laboratory designated by the sponsor. Plasma/serum samples will be collected in Cycle 1, Cycle 2 and Cycle 4 on: Day 1 (predose, end of infusion, 1-2 hours post-infusion and 2-4 hours post-infusion), on Day 8 (predose and end of infusion), and on Day 15 (±24 hours, cycle 1 only). No collection will be performed in Arm 2C. |
| Secondary | Blood concentrations of unconjugated payload (TAM470) | Part 1 and 2 (Arm 2A/2B): At Day 1, Day 8 and Day 15 of Cycle 1, and at Day 1 and Day 8 of Cycle 2 and Cycle 4 (each cycle is 21 days). | Blood concentrations of TAM470 will be listed and summarized using descriptive statistics. The measurement of TAM470 will be performed using validated methods at a central laboratory designated by the sponsor. Plasma/serum samples will be collected in Cycle 1, Cycle 2 and Cycle 4 on: Day 1 (predose, end of infusion, 1-2 hours post-infusion and 2-4 hours post-infusion), on Day 8 (predose and end of infusion), and on Day 15 (±24 hours, cycle 1 only). No collection will be performed in Arm 2C. |
| Secondary | Number of participants with dose limiting toxicities (DLTs) during Part 2 of the study | Arm 2A/2C: 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. Arm 2C: At Day 1, Day 8 and Day 15 of the first 28-day cycle, and up to Day 1 of the second 28-day cycle. | The nature and frequency of DLTs will be assessed. |
| Secondary | Number of participants with treatment emergent adverse events (TEAEs) during Part 2 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. |
| Secondary | Changes in body temperature during Part 2 of the study | Arm 2A/2B: Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). Arm 2C: Screening visit, Day 1 and Day 8 of each 28-day cycle 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. |
| Secondary | Changes in blood pressure (BP) during Part 2 of the study | Arm 2A/2B: Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). Arm 2C: Screening visit, Day 1 and Day 8 of each 28-day cycle 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. |
| Secondary | Changes in pulse rate during Part 2 of the study | Arm 2A/2B: Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). Arm 2C: Screening visit, Day 1 and Day 8 of each 28-day cycle 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. |
| Secondary | Changes in electrocardiogram (ECG) PR interval during Part 2 of the study | Arm 2A/2B: Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). Arm 2C: Screening visit, Day 1 and Day 8 of each 28-day cycle 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). |
| Secondary | Changes in electrocardiogram (ECG) QRS interval during Part 2 of the study | Arm 2A/2B: Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). Arm 2C: Screening visit, Day 1 and Day 8 of each 28-day cycle 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). |
| Secondary | Changes in electrocardiogram (ECG) QT interval during Part 2 of the study | Arm 2A/2B: Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). Arm 2C: Screening visit, Day 1 and Day 8 of each 28-day cycle 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). |
| Secondary | Changes in electrocardiogram (ECG) Fridericia correction QT (QTcF) interval during Part 2 of the study | Arm 2A/2B: Screening visit, Day 1 and Day 8 of each 21-day cycle through the study until treatment discontinuation (average of 4 months). Arm 2C: Screening visit, Day 1 and Day 8 of each 28-day cycle 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). |
| Secondary | Changes in concentration of serum chemistry parameters during Part 2 of the study | At Screening visit, at Day 1, Day 8 and Day 15 of Cycle 1 and Cycle 2, and at Day 1 and Day 8 of subsequent cycles through the study until treatment discontinuation (average of 4 months) (Arm 2A/2B: each cycle is 21 days; Arm 2C: each cycle is 28 days). | 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. |
| Secondary | Changes in concentration of hematology parameters during Part 2 of the study | At Screening visit, at Day 1, Day 8 and Day 15 of Cycle 1 and Cycle 2, and at Day 1 and Day 8 of subsequent cycles through the study until treatment discontinuation (average of 4 months) (Arm 2A/2B: each cycle is 21 days; Arm 2C: each cycle is 28 days). | 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. |
| Secondary | Treatment modifications during Part 2 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. |
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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