Trial · NCT07044908
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose limiting toxicity (DLT) | Baseline up to 48 weeks | One or more unacceptable toxic reactions following administration of the drug, resulting in the inability to continue increasing the dose or prolonging the dosing cycle. |
| Primary | Objective Response Rate (ORR) | Complete response time was achieved, evaluation is expected to take 1 years. | Proportion of patients with tumour volume reduction to a pre-specified value that maintains the minimum timeframe requirement. |
| Secondary | Maximum tolerated dose (MTD) | Baseline up to 48 weeks | If dose limiting toxicity (DLT) occurs in 2 or more subjects in a given dose group, the dose level in the previous dose group is considered MTD. |
| Secondary | Incidence of adverse event (AE) and serious adverse event (SAE) | Baseline up to 48 weeks | The incidence and severity of adverse events were determined according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 rating scale |
| Secondary | Disease Control Rate (DCR) | Complete response time was achieved, evaluation is expected to take 1 years. | The proportion of subjects who achieved complete response (CR), partial response (PR), or stable disease (SD) was assessed. |
| Secondary | Recommended Phase 2 Dose | Baseline up to 48 weeks | The dose recommended for Phase 2 trials based on Phase 1 safety, tolerability, and pharmacokinetic data. |
| Secondary | Elimination Half-life | Baseline up to 48 weeks | The time required for the plasma concentration of a drug to decrease by 50% during the elimination phase, reflecting metabolic and excretory rates. |
| Secondary | Area Under the Curve | Baseline up to 48 weeks | The integral of the drug concentration-time curve in plasma, representing total systemic drug exposure. |
| Secondary | Apparent Clearance | Baseline up to 48 weeks | The apparent volume of plasma cleared of the drug per unit time, typically expressed in L/h. |
| Secondary | Apparent Volume of Distribution in Terminal Phase | Baseline up to 48 weeks | The apparent volume in which a drug is distributed during the terminal phase, calculated based on plasma concentration, indicating tissue distribution extent. |
| Secondary | Trough Concentration | Baseline up to 48 weeks | The plasma drug concentration measured at the end of a dosing interval (before next administration), used to assess accumulation risk. |
| Secondary | Duration of Response | Complete response time was achieved, evaluation is expected to take 1 years. | Time from first documented objective response (e.g., tumor shrinkage) to disease progression or death. |
| Secondary | Progression-Free Survival | 1 year of assessment is expected from the start of enrolment to the first occurrence of disease progression or death from any cause | Time from enrollment to disease progression or death from any cause, evaluating treatment's disease control ability. |
| Secondary | Incidence of Anti-Drug Antibody | Baseline up to 48 weeks | The proportion of patients developing antidrug antibodies during treatment, indicating immunogenicity risk. |
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/NCT07044908/registered