Trial · NCT05483933
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Evaluate Safety and Tolerability of SL-172154 When Administered With PLD or Mirvetixumab | From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months | Subjects who received at least one dose of SL-172154, PLD or Mirvetixumab | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab | approximately 24 months | Response Evaluable Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Immunogenicity to SL-172154 | approximately 24 months | Immunogenicity population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Immunogenicity to MIRV | approximately 24 months | Immunogenicity population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Maximum Serum Concentration (Cmax) of SL-172154 | C1D8, C1D15, C2D8 | PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Serum Concentration-time Curve (AUC) of SL-172154 | C1D8, C1D15 and C2D8 | PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis | h*ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time at Which Maximum Concentration of SL-172154 is Observed (Tmax) | C1D8, C1D15 and C2D8 | PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis. | hours | MEDIAN |
| SECONDARY | Maximum Serum Concentration (Cmax) of MIRV | Day 1 of each cycle, pre-dose and end of infusion (EOI) | PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis | ng/mL | GEOMETRIC_MEAN |
| PRIMARY | Establish the Recommended Phase 2 Dose (RP2D) for SL-172154 When Administered With PLD or Mirvetixumab | From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months | DLT evaluable population (Dose Escalation only) | mg/kg | NUMBER |
| SECONDARY | Maximum Serum Concentration (Cmax) of Total Antibody (MIRV) | Day 1 of each cycle, pre-dose and end of infusion (EOI) | PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Serum Concentration (Cmax) of DM4 Payload and S-Methyl DM4 Payload (MIRV) | Day 1 of each cycle, pre-dose and end of infusion (EOI) | PK Population - number analyzed may be less than the number of participants in a given cohort if samples were below the limit of quantitation or not available for analysis. | ng/mL | GEOMETRIC_MEAN |
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.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05483933/outcomes