Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
Ifinatamab deruxtecan (I-DXd): A total anti-B7H3 antibody and MAAA-1181a
Study summary
This is a single group study of participants with advanced solid tumors who have not been cured by other treatments. It is the first time the drug will be used in humans, and will be in two parts.
The primary purpose of the parts are:
* Dose Escalation Part: To evaluate the safety and tolerability and to determine the maximum tolerated dose and the recommended dose for expansion of ifinatamab deruxtecan (I-DXd).
* Dose Expansion Part: To investigate the safety, tolerability and antitumor activity of I-DXd when administered as a single agent.
This study is expected to last approximately 5 years from the time the first participant is enrolled to the time the last participant is off the study.
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.
Eligibility
Primary outcome measure(s)
- Evaluate the incidence of dose-limiting toxicities (DLTs) — Day 1 to Day 21 in Cycle 1 in the dose escalation part
- Evaluate the incidence of adverse events (AEs) — Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
- Investigate the antitumor activity of ifinatamab deruxtecan (I-DXd) — Cycle 1 Day 1 through disease progression within 8 cycles (each cycle is 21 days)
Trial sites (23)
| Facility | City | Region | Status |
|---|---|---|---|
| Sarah Cannon Research Institute at HealthONE | Denver | Colorado | |
| Florida Cancer Specialists | Sarasota | Florida | |
| Dana Farber Cancer Institute | Boston | Massachusetts | |
| Henry Ford Hospital | Detroit | Michigan | |
| Washington University | St Louis | Missouri | |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | |
| Memorial Sloan-Kettering Cancer Center | New York | New York | |
| SCRI Oncology Partners | Nashville | Tennessee | |
| Tennessee Oncology | Nashville | Tennessee | |
| MDACC (MD Anderson Cancer Center) | Houston | Texas | |
| Aichi Cancer Center Hospital | Aichi | Japan | |
| National Cancer Center Hospital East | Chiba | Japan | |
| Hokkaido University Hospital | Hokkaido | Japan | |
| Kobe City Medical Center General Hospital | Hyōgo | Japan | |
| Kagawa University Hospital | Kagawa | Japan | |
| The University of Osaka Hospital | Osaka | Japan | |
| Kindai University Hospital | Ōsaka-sayama | Japan | |
| Saitama Cancer Center | Saitama | Japan | |
| Shizuoka Cancer Center | Shizuoka | Japan | |
| National Cancer Center Hospital | Tokyo | Japan | |
| Cancer Institute Hospital of JFCR | Tokyo | Japan | |
| Showa Medical University Hospital | Tokyo | Japan | |
| Keio University Hospital | Tokyo | Japan |
More Daiichi Sankyo trials in Japan
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04145622 on ClinicalTrials.gov ↗ ← All trials in Japan