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Trial · NCT07287995

A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors

NCT07287995, Phase 1, Phase 2, Recruiting, Astellas Pharma Global Development, Inc.

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors. Trials, record NCT07287995. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07287995

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors
NCT number
NCT07287995
Status
Recruiting
Phases
Phase 1, Phase 2
Enrollment
428 participants, estimated
Lead sponsor
Astellas Pharma Global Development, Inc.
Conditions
Locally Advanced or Metastatic Malignant Solid Tumors
Interventions
ASP2998, Pembrolizumab, Enfortumab Vedotin, Carboplatin
First posted
2025-12-17
Last updated
2026-10-22

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber 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.
PrimaryNumber 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.
PrimaryNumber of participants with laboratory value abnormalities and/or adverse events (AEs)Up to 21 monthsNumber of participants with potentially clinically significant laboratory values.
PrimaryNumber of participants with vital sign abnormalities and/or AEsUp to 19 monthsNumber of participants with potentially clinically significant vital sign values.
PrimaryNumber of participants with electrocardiogram (ECG) abnormalities and/or AEsUp to 19 monthsNumber of participants with potentially clinically significant ECG values.
PrimaryNumber of Participants with Physical Examination (PE) abnormalities and/or AEsUp to 19 monthsNumber of participants with potentially clinically significant PE values.
PrimaryNumber of Participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status scoreUp 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.
SecondaryObjective Response Rate (ORR) of ASP2998 per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1Up to 27 monthsORR 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.
SecondaryDuration of Response (DOR) of ASP2998 per RECIST v1.1Up 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.
SecondaryDisease Control Rate (DCR) of ASP2998 per RECIST v1.1Up to 27 monthsDCR 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.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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 trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07287995

GET https://conductscience.org/api/trials/v1/NCT07287995/registered