Trial · NCT07912268
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting toxicity(DLT) (Dose escalation) | During the first cycle treatment with SIM0518 | DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria. |
| Primary | Adverse event Rate | Up to approximately 24 months | The occurrence of all adverse events (AEs), evaluated by Common Terminology Criteria for Adverse Events (CTCAE)6.0. |
| Primary | Adverse event Severity | Up to approximately 24 months | The Severity of all adverse events (AEs), evaluated by Common Terminology Criteria for Adverse Events（CTCAE）6.0. |
| Primary | Serious Adverse Event Rate | Up to approximately 24 months | The Occurrence of Serious Adverse Event Rate According to the Protocol |
| Primary | Serious Adverse Event Severity | Up to approximately 24 months | The Severitye of Serious Adverse Event Rate According to the Protocol |
| Primary | Objective Response Rate (ORR) | Up to approximately 24 months | ORR is the proportion of subjects with complete response（CR）or partial response(PR) assessed according to RECIST v1.1. |
| Secondary | Pharmacokinetics: The area under the curve (AUC) | Up to approximately 24 months | The area under the curve (AUC) of serum concentration of SIM0518 |
| Secondary | Pharmacokinetics:Peak concentration (Cmax) | Up to approximately 24 months | Maximum observed concentration (Cmax) of SIM0518 |
| Secondary | Pharmacokinetics: T1/2 | Up to approximately 24 months | Terminal half-life (T1/2) |
| Secondary | Pharmacokinetics: Tmax | Up to approximately 24 months | Time to maximum concentration |
| Secondary | Pharmacokinetics: Ctrough | Up to approximately 24 months | Minimum observed concentration (Cmax) of SIM0518 |
| Secondary | Duration of Response (DOR) | Up to approximately 24 months | DOR is the time from the date of first documented complete response (CR) or partial response (PR) to the earliest date of progressive disease (PD) or death from any cause, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1. |
| Secondary | Disease Control Rate (DCR) | Up to approximately 24 months | DCR is the proportion of participants with complete response (CR), partial response (PR) or stable disease (SD) assessed according to Response Evaluation Criteria in Solid Tumors version 1.1. |
| Secondary | Time To Response (TTR) | Up to approximately 24 months | TTR is the time from the date of study treatment initiation to the date of first documented complete response (CR) or partial response (PR), assessed according to Response Evaluation Criteria in Solid Tumors version 1.1. |
| Secondary | Intracranial Objective Response Rate (IC-ORR) | Up to approximately 24 months | IC-ORR is the proportion of participants with complete response (CR) or partial response (PR) for intracranial lesions assessed according to Response Evaluation Criteria in Solid Tumors version 1.1. |
| Secondary | Intracranial Disease Control Rate (IC-DCR) | Up to approximately 24 months | IC-DCR is the proportion of participants with complete response (CR), partial response (PR) or stable disease (SD) for intracranial lesions assessed according to Response Evaluation Criteria in Solid Tumors version 1.1. |
| Secondary | Intracranial Duration of Response (IC-DOR) | Up to approximately 24 months | IC-DOR is the time from the date of first documented complete response (CR) or partial response (PR) for intracranial lesions to the earliest date of intracranial progressive disease (PD) or death from any cause, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1. |
| Secondary | Intracranial Time To Response (IC-TTR) | Up to approximately 24 months | IC-TTR is the time from the date of study treatment initiation to the date of first documented complete response (CR) or partial response (PR) for intracranial lesions, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1. |
| Secondary | Intracranial Progression-Free Survival (IC-PFS) | Up to approximately 24 months | IC-PFS is the time from the date of study treatment initiation to the earliest date of intracranial progressive disease (PD) or death from any cause, assessed according to Response Evaluation Criteria in Solid Tumors version 1.1. |
| Secondary | Objective Response Rate (ORR) (Part 1) | Up to approximately 24 months | ORR is the proportion of participants with complete response (CR) or partial response (PR) assessed according to Response Evaluation Criteria in Solid Tumors version 1.1. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07912268/registered