Study · A Phase 1 Study to Evaluate…
A Phase 1 Study to Evaluate Intratumoral Doxorubicin Exposure Following Administration of Aldoxorubicin or Doxorubicin
startupAldoxorubicin 350 mg/m² vs doxorubicin 75 mg/m² (single dose, intratumoral PK bridging)
Phase I Soft-tissue sarcoma Sponsor Gemini Therapeutics (IND 113695)
Study design
- Design
- Phase 1, open-label, randomized 1:1, parallel, single-dose PK-bridging open-label
- Arms (2)
- Aldoxorubicin 350 mg/m2Doxorubicin 75 mg/m2
- Primary endpoint
- 90% CI of the mean ratio of intratumoral doxorubicin concentration (aldoxorubicin vs doxorubicin) at Day 2 biopsy
- Enrollment
- 0 of 36 target
- Provenance
-
Gemini Therapeutics aldoxorubicin intratumoral PK bridging study — protocol synopsis draft 1 (2026-08-12, DR/JJ). REAL sponsor draft synopsis; the study has not started, so there are no subjects or clinical records. The 4 sites below are the planned US institutions (MD Anderson, Sylvester/Miami, Duke, Northwestern); their contract dates and stages, and the PI names GalenOps assigns them, are FICTIONAL demo values for the site activation / contracting agents.
- LicenseSponsor-internal draft — demo use inside GalenOps only; not for distribution
- Upstreamgalenops/docs/Aldox tumor PK study_synopsis_draft1_20260812 DR_JJ.docx (cleaned Markdown copy: priv/demo_data/aldox_synopsis.md)
- Extracted 2026-09-19
Agentic orchestration
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Study lifecycle checklist 0 / 13
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Decisions awaiting you 0
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Protocol versions 1
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Sites 4
Every site contracted for this study or with a participant on it — with this study's contract stage and enrollment. Open a site for its full monitoring picture.
| Site | Country | Principal investigator | Site status | Contract | Participants | Risk |
|---|---|---|---|---|---|---|
| Sylvester Comprehensive Cancer Center, University of Miami (Miami, FL) | USA | Dr. Nolan | activated | executed 2026-07-28 | 0 enrolled · 1 on site | unscored |
| The University of Texas MD Anderson Cancer Center (Houston, TX) | USA | Dr. Reyes | activated | executed 2026-07-10 | 0 enrolled · 1 on site | unscored |
| Duke Cancer Institute (Durham, NC) | USA | Dr. Okafor | in_activation | pending sent 2026-07-13 | 0 enrolled · 0 on site | unscored |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University (Chicago, IL) | USA | Dr. Tanaka | in_activation | pending sent 2026-08-12 | 0 enrolled · 0 on site | unscored |
Feasibility 0
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Regulatory submissions 0
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