Active — Not RecruitingPhase 1

First-in-human Study of DS-1062a for Advanced Solid Tumors (TROPION-PanTumor01)

United States890 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 range18 Years

SexALL

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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 …

What they're measuring

Number of participants with dose-limiting toxicities

Timeframe: Within 8 cycles (each cycle is 21 days)

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)

Number of participants with Grade >/= 2 oral mucositis/stomatitis in Sub-Study

Timeframe: At 8 weeks

Trial details

NCT IDNCT03401385

SponsorDaiichi Sankyo Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-01-01

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