Trial · NCT07909356
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose of study drug through 30 days after the last dose (up to approximately 36 months) | Incidence and severity of AEs and SAEs, including clinically significant changes in laboratory parameters, vital signs, and ECGs, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0. |
| Primary | Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) in Part A (Dose Escalation) | Cycle 1 (Day 1 to Day 21) | A DLT is defined as any protocol-specified treatment-related hematologic, non-hematologic, or cardiac (QTcF) toxicity graded per NCI CTCAE v6.0 occurring during the DLT evaluation period. The incidence of DLTs in Cycle 1 is used to determine the Maximum Tolerated Dose (MTD, defined as the highest dose level at which ≤1 of 6 participants experiences a DLT) and Recommended Dose for Expansion (RDE). |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of MC001 (ADC), Total Antibody, and Unconjugated MMAE | Cycle 1 (Days 1, 2, 8, and 15) and Day 1 of subsequent 21-day cycles (up to approximately 36 months) | Plasma Cmax derived from intensive blood sampling in Cycle 1 and sparse sampling in subsequent cycles. |
| Secondary | Area Under the Plasma Concentration-Time Curve (AUC) of MC001 (ADC), Total Antibody, and Unconjugated MMAE | Cycle 1 (Days 1, 2, 8, and 15) and Day 1 of subsequent 21-day cycles (up to approximately 36 months) | Plasma AUC derived from pharmacokinetic blood sampling. |
| Secondary | Terminal Elimination Half-Life (T1/2) of MC001 (ADC), Total Antibody, and Unconjugated MMAE | Cycle 1 (Day 1 through Day 15) | Terminal half-life calculated from plasma concentration-time profiles during Cycle 1. |
| Secondary | Objective Response Rate (ORR) | From first dose of study drug until disease progression or treatment discontinuation (assessed prior to Cycles 3 and 5, and every 3 cycles thereafter, up to approximately 36 months) | Proportion of participants in the response-evaluable analysis set achieving a confirmed Complete Response (CR) or Partial Response (PR) as determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. |
| Secondary | Duration of Response (DoR) | From date of first documented CR or PR until disease progression or death (up to approximately 36 months) | Time from the date of first documented confirmed objective response (CR or PR) to the date of first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first. |
| Secondary | Disease Control Rate (DCR) | From first dose of study drug until disease progression or treatment discontinuation (up to approximately 36 months) | Proportion of participants achieving CR, PR, or Stable Disease (SD, maintained for ≥6 weeks from start of treatment) as their best overall response per RECIST v1.1. |
| Secondary | Progression-Free Survival (PFS) | From first dose of study drug until disease progression or death (up to approximately 36 months) | Time from the date of the first dose of MC001 to the date of first documented progressive disease per RECIST v1.1 or death due to any cause, whichever occurs first. |
| Secondary | Overall Survival (OS) | From first dose of study drug until death from any cause (up to approximately 36 months) | Time from the date of the first dose of MC001 to the date of death due to any cause. |
| Secondary | Percentage of Participants With Anti-Drug Antibodies (ADAs) to MC001 | Screening, Cycle 1 (Days 1, 8, 15), Cycle 2 Day 1, Cycle 3 Day 1, every 2nd cycle thereafter, End of Treatment, and 30 and 90 days post-last dose (up to approximately 36 months) | Incidence and persistence of treatment-emergent anti-drug antibodies (ADAs) evaluated via a tiered analytical approach (screening, confirmatory, and titer assays). |
| Secondary | Concentration-QTc Relationship: Change From Baseline in Fridericia-Corrected QT Interval (ΔQTcF) | Cycle 1 (Day 1 pre-dose through 24 hours post-infusion, Day 8, and Day 14), Cycle 3 Day 1, and Cycle 6 Day 1 | Relationship between plasma MC001 concentrations and change from baseline in QTcF (ΔQTcF) evaluated via continuous Holter ECG monitoring paired with time-matched PK sampling. |
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/NCT07909356/registered