First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01) (NCT03401385)
Phase 1, Two-part, Multicenter, Open-label, Multiple Dose, First-in-human Study of DS-1062a in Subjects With Advanced Solid Tumors (TROPION-PanTumor01)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: University of California, Los Angeles — Los Angeles, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (18 Sites)
- University of California, Los Angeles — Los Angeles, California
- Johns Hopkins Sibley Memorial Hospital — Washington D.C., District of Columbia
- Winship Cancer Institute of Emory University — Atlanta, Georgia
- Johns Hopkins University — Baltimore, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Tisch Cancer Institute, Icahn School of Medicine — New York, New York
- Memorial Sloan-Kettering Cancer Center — New York, New York
- Sarah Cannon Research Institute — Nashville, Tennessee
- MD Anderson Cancer Center — Houston, Texas
- Next Oncology — San Antonio, Texas
- START Oncology — San Antonio, Texas
- Virginia Cancer Specialists — Fairfax, Virginia
- Aichi Cancer Center — Nagoya, Aichi-ken
- The Cancer Institute Hospital of Japanese Foundation For Cancer Research — Koto-Ku, Tokyo
- Showa Medical University Hospital — Shinagawa-Ku, Tokyo
- National Cancer Center Hospital — Chūōku,
- National Cancer Center Hospital East — Kashiwa,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.