Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 1

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

NCT04145622 · View on ClinicalTrials.gov ↗

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.

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

157 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04145622

The ClinicalTrials.gov registry entry for NCT04145622 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 157 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04145622 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Other, Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04145622?

The interventions under investigation include: Ifinatamab deruxtecan (I-DXd) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04145622?

This trial is sponsored by Daiichi Sankyo, which has 157 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial