Trial · NCT05483933
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Number of participants with treatment emergent adverse events from dose escalation and expansion cohorts |
| 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 | Based on review of all data, including safety, tolerability, PK, antitumor activity, and PD effects" |
| Secondary | To Assess Preliminary Evidence of Anti-tumor Activity of SL-172154 When Administered With PLD or Mirvetixumab | approximately 24 months | Overall response rate per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1) |
| Secondary | Immunogenicity to SL-172154 | approximately 24 months | Number and proportion of participants with positive anti-drug antibody titer of those who were ADA negative at baseline |
| Secondary | Immunogenicity to MIRV | approximately 24 months | Number and proportion of participants with positive anti-drug antibody titer of those who were ADA negative at baseline |
| Secondary | Maximum Serum Concentration (Cmax) of SL-172154 | C1D8, C1D15, C2D8 | The Cmax is the maximum observed serum concentration of SL-172154 following single and multiple doses |
| Secondary | Area Under the Serum Concentration-time Curve (AUC) of SL-172154 | C1D8, C1D15 and C2D8 | The AUC is the area under the serum concentration time curve of SL-172154 following single and multiple doses |
| Secondary | Time at Which Maximum Concentration of SL-172154 is Observed (Tmax) | C1D8, C1D15 and C2D8 | The Tmax is the time at which the maximum concentration of SL-172154 is observed following single and multiple doses |
| Secondary | Maximum Serum Concentration (Cmax) of MIRV | Day 1 of each cycle, pre-dose and end of infusion (EOI) | The Cmax is the maximum observed serum concentration of MIRV following single and multiple doses |
| Secondary | Maximum Serum Concentration (Cmax) of Total Antibody (MIRV) | Day 1 of each cycle, pre-dose and end of infusion (EOI) | The Cmax is the maximum observed serum concentration of Total Antibody (MIRV) following single and multiple doses |
| 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) | The Cmax is the maximum observed serum concentration of DM4 Payload and S-Methyl DM4 payload following single and multiple doses |
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
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GET https://conductscience.org/api/trials/v1/NCT05483933/registered