Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
Public ClinicalTrials.gov record NCT04145622. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase I/II, Two-Part, Multicenter First-in-Human Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Subjects With Advanced Solid Malignant Tumors (IDeate-PanTumor01)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04145622
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 250 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 2, 2019
- Primary completion
- Apr 29, 2027
- Completion
- Oct 30, 2029
- Last update posted
- May 28, 2026
2019 – 2029
United States locations
- U.S. sites
- 15
- U.S. states
- 12
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Center- Samuel Oschin Comprehensive Cancer Institute | Los Angeles | California | 90048 | Withdrawn |
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | 80218 | Recruiting |
| Florida Cancer Specialists | Orlando | Florida | 32804 | Withdrawn |
| Florida Cancer Specialists | Sarasota | Florida | 34232 | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | Active, not recruiting |
| Henry Ford Hospital | Detroit | Michigan | 48202 | Active, not recruiting |
| Washington University | St Louis | Missouri | 63110 | Active, not recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | Recruiting |
| Columbia University Medical Center | New York | New York | 10032 | Withdrawn |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | Active, not recruiting |
| The Ohio State University | Columbus | Ohio | 43210 | Withdrawn |
| Sidney Kimmel Cancer Center - Thomas Jefferson | Philadelphia | Pennsylvania | 19107 | Withdrawn |
| SCRI Oncology Partners | Nashville | Tennessee | 37203 | Active, not recruiting |
| Tennessee Oncology | Nashville | Tennessee | 37203 | Active, not recruiting |
| MDACC (MD Anderson Cancer Center) | Houston | Texas | 77030 | Active, not recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04145622, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 28, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04145622 live on ClinicalTrials.gov.