First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)
Public ClinicalTrials.gov record NCT03401385. 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 1, Two-part, Multicenter, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects With Advanced Solid Tumors (TROPION-PanTumor01)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is one single group of participants with non-small cell lung cancer (NSCLC) who have not been cured by other treatments. It is the first time the drug has been used in humans. There will be two parts and a sub-study. The primary purpose of the parts are: * Dose Escalation: To investigate the safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DS-1062a * Dose Expansion: To investigate the safety and tolerability of DS-1062a in additional solid tumors This study is expected to last approximately 6 years from the time the first participant is enrolled to the time the last subject is off the study. Study sites are located in both the United States and Japan. 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. The primary purpose of the sub-study is to compare the effectiveness of steroid versus non-steroid mouthwash as prophylaxis against oral mucositis/stomatitis in participants receiving DS-1062a. The sub-study is a randomized study that will include approximately 76 participants enrolling into the Dose Expansion part.
Study identification
- NCT ID
- NCT03401385
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 890 participants
Conditions and interventions
Conditions
Interventions
- Datopotamab Deruxtecan (Dato-DXd) Drug
- Steroid Containing Mouthwash Drug
- Non-Steroid Containing Mouthwash Other
Drug · Other
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
- Jan 30, 2018
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
- Last update posted
- Aug 31, 2026
2018 – 2028
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90095 | — |
| Johns Hopkins Sibley Memorial Hospital | Washington D.C. | District of Columbia | 20016 | — |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| Tisch Cancer Institute, Icahn School of Medicine | New York | New York | 10029 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37205 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Next Oncology | San Antonio | Texas | 78229 | — |
| START Oncology | San Antonio | Texas | 78229 | — |
| Virginia Cancer Specialists | Fairfax | Virginia | 22031 | — |
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 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03401385, 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 Aug 31, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03401385 live on ClinicalTrials.gov.