Trial · NCT07899632
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 (Dose Escalation): Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From informed consent (Cycle 0 Day -28) through 30 days after the last dose of study treatment (30-day safety follow-up). Each cycle is 28 days. | |
| Primary | Part 1 (Dose Escalation): Number of Participants With Serious Adverse Events (SAEs) | From informed consent (Cycle 0 Day -28) through 30 days after the last dose of study treatment (30-day safety follow-up). Each cycle is 28 days | |
| Primary | Part 1 (Dose Escalation): Number of Participants With Adverse Events of Special Interest (AESIs) | From informed consent (Cycle 0 Day -28) through 30 days after the last dose of study treatment (30-day safety follow-up). Each cycle is 28 days | |
| Primary | Part 1 (Dose Escalation): Number of Participants With Treatment-Related Adverse Events (TRAEs) | From informed consent (Cycle 0 Day -28) through 30 days after the last dose of study treatment (30-day safety follow-up). Each cycle is 28 days | |
| Primary | Part 1 (Dose Escalation): Number of Participants With Dose Interruptions Due to Adverse Events | From informed consent (Cycle 0 Day -28) through 30 days after the last dose of study treatment (30-day safety follow-up). Each cycle is 28 days | |
| Primary | Part 1 (Dose Escalation): Number of Participants With Treatment Discontinuations Due to Adverse Events | From informed consent (Cycle 0 Day -28) through 30 days after the last dose of study treatment (30-day safety follow-up). Each cycle is 28 days | |
| Primary | Part 1 (Dose Escalation): Number of Participants With Infusion-Related Reactions (IRRs) | From informed consent (Cycle 0 Day -28) through 30 days after the last dose of study treatment (30-day safety follow-up). Each cycle is 28 days | |
| Primary | Part 1 (Dose Escalation): Number of Participants With Dose-Limiting Toxicities (DLTs) | During the Dose-Limiting Toxicity (DLT) evaluation period from Cycle 1 Day 1 through Day 22 of Cycle 1. | |
| Secondary | Part 1 (Dose Escalation): Maximum Observed Plasma Concentration (Cmax) of MDSY-1240 | PK samples collected from Cycle 1 Day 1 through Cycle 2 Day 1. | |
| Secondary | Part 1 (Dose Escalation): Time to Maximum Plasma Concentration (Tmax) of MDSY-1240 | PK samples collected from Cycle 1 Day 1 through Cycle 2 Day 1. | |
| Secondary | Part 1 (Dose Escalation): Terminal Elimination Half-Life (t½) of MDSY-1240 | PK samples collected from Cycle 1 Day 1 through Cycle 2 Day 1. | |
| Secondary | Part 1 (Dose Escalation): Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-t) of MDSY-1240 | PK samples collected from Cycle 1 Day 1 through Cycle 2 Day 1. | |
| Secondary | Part 1 (Dose Escalation): Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of MDSY-1240 | PK samples collected from Cycle 1 Day 1 through Cycle 2 Day 1. | |
| Secondary | Part 1 (Dose Escalation): Apparent Clearance (CL) of MDSY-1240 | PK samples collected from Cycle 1 Day 1 through Cycle 2 Day 1. | |
| Secondary | Part 1 (Dose Escalation): Volume of Distribution at Steady State (Vss) of MDSY-1240 | PK samples collected from Cycle 1 Day 1 through Cycle 2 Day 1. | |
| Secondary | Part 1 (Dose Escalation): Change From Baseline in Total STAT3 Protein Levels in PBMCs | From informed consent (Cycle 0 Day -28) through the end of Cycle 2 (each cycle is 28 days). | |
| Secondary | Part 1 (Dose Escalation): Change From Baseline in Phosphorylated STAT3 (pSTAT3) Protein Levels in PBMCs | From informed consent (Cycle 0 Day -28) through the end of Cycle 2 (each cycle is 28 days). | |
| Secondary | Part 1 (Dose Escalation): Time to Response (TTR) according to disease-specific response criteria | Through study completion, an average of 24 months | |
| Secondary | Clinical Benefit Rate (CBR) according to disease-specific response criteria | Through study completion, an average of 24 months | |
| Secondary | Objective Response Rate (ORR) according to disease-specific response criteria. | From first dose through disease assessments, up to approximately 24 months |
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.
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GET https://conductscience.org/api/trials/v1/NCT07899632/registered