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: To join this study, participants generally need to meet the listed inclusion criteria (50 items) and avoid the listed exclusions (25 items).
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 ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Has a history of malignancy, other than a tumor type specified in the Inclusion Criteria, except (a) adequately resected non-melanoma skin cancer, (b) curatively treated in situ disease, or (c) other solid tumors curatively treated, with no evidence of disease for ≥3 years.
- Uncontrolled or significant cardiac disease including myocardial infarction or uncontrolled/unstable angina within 6 months prior to Cycle 1 Day 1.
- History of congestive heart failure (New York Heart Association classes II-IV) or uncontrolled or significant cardiac arrhythmia, uncontrolled hypertension(resting systolic blood pressure \>180 mm Hg or diastolic blood pressure \>110 mm Hg).
- Has a mean corrected QT interval (QTcF) prolongation to \>470 ms based on of the screening triplicate 12-lead ECGs.
- Has a history of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Has clinically significant corneal disease.
- Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals. Has active human immunodeficiency virus (HIV) infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA load, CD4+ count \>350, no history of AIDS-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications. If an HIV infection meets the above criteria, monitoring of viral RNA load and CD4+ count is recommended. Subjects/participants must be tested for HIV during the Screening Period if acceptable by local regulations or an IRB/IEC.
- Has an active or uncontrolled hepatitis B and/or hepatitis C infection.
- Has spinal cord compression or clinically active brain metastases, defined as untreated and symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with steroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy.
- Is lactating or pregnant as confirmed by pregnancy tests performed within 7 days before enrollment.
- Has unresolved toxicities from previous anticancer therapy.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 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.
- 💵 Compensation indicated: The dosage strength will change during the study but all participants will receive the same study drug.
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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.