Trial · NCT07287995
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with Dose Limiting Toxicities (DLTs) | Up to 21 days | A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 Day 1 (C1D1) that cannot clearly be attributed to a cause other than ASP2998 administered in monotherapy or in combination with standard treatments. |
| Primary | Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | Up to 21 Months | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. NOTE: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of study intervention. This includes events related to the comparator, if applicable, and events related to the (study) procedures. A TEAE is an AE with onset at any time from first dosing until last scheduled procedure. |
| Primary | Number of participants with laboratory value abnormalities and/or adverse events (AEs) | Up to 21 months | Number of participants with potentially clinically significant laboratory values. |
| Primary | Number of participants with vital sign abnormalities and/or AEs | Up to 19 months | Number of participants with potentially clinically significant vital sign values. |
| Primary | Number of participants with electrocardiogram (ECG) abnormalities and/or AEs | Up to 19 months | Number of participants with potentially clinically significant ECG values. |
| Primary | Number of Participants with Physical Examination (PE) abnormalities and/or AEs | Up to 19 months | Number of participants with potentially clinically significant PE values. |
| Primary | Number of Participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status score | Up to 19 months | The ECOG scale will be used to assess performance status. Scores range from 0 (fully active) to 5 (dead). Negative change scores represent an improvement. Positive scores represent a decline in performance. |
| Secondary | Objective Response Rate (ORR) of ASP2998 per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Up to 27 months | ORR is defined as the proportion of participants whose best overall response is rated as Complete Response (CR) or Partial Response (PR) per RECIST v1.1 as assessed by the investigator. |
| Secondary | Duration of Response (DOR) of ASP2998 per RECIST v1.1 | Up to 27 months | DOR is defined as the time from the date of first documented response (CR or PR that is subsequently confirmed) to the date of first documented progressive disease (PD) per RECIST v1.1 as assessed by the investigator or death due to any cause, whichever occurs first. |
| Secondary | Disease Control Rate (DCR) of ASP2998 per RECIST v1.1 | Up to 27 months | DCR is defined as the proportion of participants whose best overall response is rated as CR, PR or stable disease (SD) per RECIST v1.1 as assessed by the investigator. |
| Secondary | Progression Free Survival (PFS) per RECIST v1.1 | Up to 27 months | PFS is defined as the time from the first dose of study intervention until the date of documented PD per RECIST v1.1 as assessed by the investigator or until death for any cause, whichever comes first. |
| Secondary | Overall Survival (OS) | Up to 33 months | OS is defined as the time from the first dose of study intervention until death due to any cause. |
| Secondary | Pharmacokinetics (PK) of ASP2998 in plasma: area under the concentration-time curve at 21 days (AUC21d) | Up to 18 months | AUC21d will be recorded from the PK plasma samples collected. |
| Secondary | PK of ASP2998 in plasma: maximum concentration (Cmax) | Up to 18 months | Cmax will be recorded from the PK plasma samples collected. |
| Secondary | PK of ASP2998 in plasma: trough concentration (Ctrough) | Up to 18 months | Ctrough will be recorded from the PK plasma samples collected. |
| Secondary | PK of ASP2998 in plasma: time of maximum concentration (tmax) | Up to 18 months | tmax will be recorded from the PK plasma samples collected. |
| Secondary | Incidence rate of trophoblast cell surface antigen 2 (TROP2) expression in tumor | Up to 18 months | Incidence rate of TROP2 expression in tumor will be evaluated from tissue samples collected. |
| Secondary | Expression levels of TROP2 in tumor | Up to 18 months | Expression levels of TROP2 expression in tumor will be evaluated from tissue samples collected. |
| Secondary | Change of TROP2 expression in tumor | Up to 18 months | Change of TROP2 expression in tumor will be evaluated from tissue samples collected. |
| Secondary | Change in CD8 T-cell lymphocytes in paired biopsies | Up to 18 months | Change in CD8 T-cell lymphocytes in paired biopsies will be evaluated from tissue samples collected. |
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/NCT07287995/registered