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NCT04145622 · ClinicalTrials.gov registry record · Phase 1

Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors

A Phase 1 study of Advanced Solid Tumor and Malignant Solid Tumor, sponsored by Daiichi Sankyo.

Recruiting
Registry status
Phase 1
Development phase
250
Enrollment target
20
Study locations

NCT04145622 is a Phase 1 study of Advanced Solid Tumor and Malignant Solid Tumor that is actively recruiting participants, run by Daiichi Sankyo. The registered enrollment target is 250 participants, above the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (30% higher). The trial reports 20 study locations across 13 states.

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The verdict

NCT04145622, a Phase 1 study of Advanced Solid Tumor and Malignant Solid Tumor, is actively recruiting participants, sponsored by Daiichi Sankyo.

RECRUITING
Registry status
Phase 1
Development phase
250 participants
Enrollment target
20
Study locations

Study Summary

This is a single group study of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts. The primary purpose of the parts are: * Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of ifinatamab deruxtecan (I-DXd). * Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of I-DXd when administered as a single agent. This study is expected to last approximately 5 years from the time the first participant is enrolled to the time the last participant is off the study. The number of treatment cycles is not fixed in this study. Participants who continue to benefit from the study treatment may continue, unless: * they withdraw * their disease gets worse * they experience unacceptable side effects.

Conditions Studied

Advanced Solid Tumor Malignant Solid Tumor

Interventions

  • DRUG Ifinatamab deruxtecan (I-DXd)

Study Locations (20)

Other

  • Aichi Cancer Center Hospital - Aichi
  • National Cancer Center Hospital East - Chiba
  • Hokkaido University Hospital - Hokkaido
  • Osaka University Hospital - Osaka
  • Kindai University Hospital - Ōsaka-sayama

Florida

  • Florida Cancer Specialists - Orlando
  • Florida Cancer Specialists - Sarasota

New York

  • Columbia University Medical Center - New York
  • Memorial Sloan-Kettering Cancer Center - New York

Tennessee

  • SCRI Oncology Partners - Nashville
  • Tennessee Oncology - Nashville

California

  • Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute - Los Angeles

Colorado

  • Sarah Cannon Research Institute at HealthONE - Denver

Massachusetts

  • Dana Farber Cancer Institute - Boston

Michigan

  • Henry Ford Hospital - Detroit

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2019-11-03
Est. Completion 2029-10-31
Phase Phase 1

Sponsor

Daiichi Sankyo

236 total trials

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What the Registry Record Tells You About NCT04145622

The ClinicalTrials.gov registry entry for NCT04145622 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (30% higher). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which Ifinatamab deruxtecan (I-DXd) is the first listed.

NCT04145622 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Other, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT04145622 about?

NCT04145622 is a clinical study titled "Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors". This is a single group study of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts. The primary purpose of the parts are: * Dose Escalation Part: To evaluate the safety and tolerability...

What is the current status of trial NCT04145622?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 250 participants. The study started on 2019-11-03. Estimated completion is 2029-10-31.

What conditions does trial NCT04145622 study?

This clinical trial studies the following conditions: Advanced Solid Tumor, Malignant Solid Tumor.

What interventions are being tested in trial NCT04145622?

The interventions under investigation include: Ifinatamab deruxtecan (I-DXd) (DRUG).

Who is sponsoring clinical trial NCT04145622?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04145622 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.