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First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)
NCT03401385 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Datopotamab Deruxtecan (Dato-DXd)
- DRUG Steroid Containing Mouthwash
- OTHER Non-Steroid Containing Mouthwash
Study Locations (18)
Texas
- MD Anderson Cancer Center — Houston
- Next Oncology — San Antonio
- START Oncology — San Antonio
Massachusetts
- Massachusetts General Hospital — Boston
- Dana-Farber Cancer Institute — Boston
New York
- Tisch Cancer Institute, Icahn School of Medicine — New York
- Memorial Sloan-Kettering Cancer Center — New York
Tokyo
- The Cancer Institute Hospital of Japanese Foundation For Cancer Research — Koto-Ku
- Showa Medical University Hospital — Shinagawa-Ku
Other
- National Cancer Center Hospital — Chūōku
- National Cancer Center Hospital East — Kashiwa
California
- University of California, Los Angeles — Los Angeles
District of Columbia
- Johns Hopkins Sibley Memorial Hospital — Washington D.C.
Georgia
- Winship Cancer Institute of Emory University — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 890 participants |
| Start Date | 2018-01-31 |
| Est. Completion | 2027-01-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03401385
The ClinicalTrials.gov registry entry for NCT03401385 describes a study currently listed as active not 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 890 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo Co., which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions — of which Datopotamab Deruxtecan (Dato-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: NCT03401385 reports 18 study locations spanning 12 distinct geographic areas — top geographies include Texas, Massachusetts, 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 NCT03401385 about?
NCT03401385 is a clinical study titled "First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)". 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 investigat...
What is the current status of trial NCT03401385?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 890 participants. The study started on 2018-01-31. Estimated completion is 2027-01-01.
What conditions does trial NCT03401385 study?
This clinical trial studies the following conditions: Non-small Cell Lung Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03401385?
The interventions under investigation include: Datopotamab Deruxtecan (Dato-DXd) (DRUG), Steroid Containing Mouthwash (DRUG), Non-Steroid Containing Mouthwash (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03401385?
This trial is sponsored by Daiichi Sankyo Co., which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03401385 being conducted?
This trial has 18 study locations across California, District of Columbia, Georgia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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