First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01) (NCT03401385) | Clinical Trial Compass
Active — Not RecruitingPhase 1
First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)
United States, Japan890 participantsStarted 2018-01-31
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
All Participants:
* Has relapsed or progressed following local standard treatments or for which no standard treatment is available.
* Consents to provide mandatory pre-treatment tumor tissue samples for the measurement of TROP2 and other biomarkers. There is no minimum TROP2 expression level required for inclusion.
* Consents to undergo mandatory on-treatment biopsy if clinically feasible and not contraindicated at the time of on-treatment biopsy, and consents to provide the tumor tissue samples from on-treatment biopsy for the measurement of TROP2 level and other biomarkers.
* Is aged ≥18 years old.
* Has an Eastern Cooperative Oncology Group performance status 0-1.
* Has a left ventricular ejection fraction (LVEF) ≥50% by either an ECHO or MUGA within 28 days before enrollment.
* Has measurable disease based on RECIST version1.1.
* Has adequate bone marrow reserve and organ function within 7 days before Cycle 1, Day 1.
* Has an adequate treatment washout period prior to Cycle 1, Day 1.
* If of reproductive/childbearing potential, agrees to use a highly effective from of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug, and agrees not to retrieve, freeze or donate sperm or ova starting at Screening and throughout the study period, and at least 7 months for males and 4 months for males after the final study drug administration.
* After …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with dose-limiting toxicities
Timeframe: Within 8 cycles (each cycle is 21 days)
2
Number of participants with adverse events (AEs)
Timeframe: When all participants have either discontinued the study or the last participant enrolled in the study has completed at least 6 months of follow up (approximately 4 years)
3
Number of participants with Grade >/= 2 oral mucositis/stomatitis in Sub-Study