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NCT06475937 · ClinicalTrials.gov registry record · Phase 1
A Study of DM001 in Patients With Advanced Solid Tumors
A Phase 1 study of Carcinoma, Non-Small Cell Lung and Breast Neoplasms, sponsored by Xadcera Biopharmaceutical (Suzhou) Co..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 128
- Enrollment target
- 5
- Study locations
NCT06475937: Recruiting Phase 1 study of Carcinoma, Non-Small Cell Lung and Breast Neoplasms, sponsored by Xadcera Biopharmaceutical (Suzhou) Co..
NCT06475937 is a Phase 1 study of Carcinoma, Non-Small Cell Lung and Breast Neoplasms that is actively recruiting participants, run by Xadcera Biopharmaceutical (Suzhou) Co.. The registered enrollment target is 128 participants, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (60% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06475937, a Phase 1 study of Carcinoma, Non-Small Cell Lung and Breast Neoplasms, is actively recruiting participants, sponsored by Xadcera Biopharmaceutical (Suzhou) Co..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 128 participants
- Enrollment target
- 5
- Study locations
Study Summary
The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM001 for patients with the advanced solid tumors. DM001 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. Participants will have up to 17 visits during the study.There will be up to a 4-week Screening Period followed by a treatment period that will be divided into 3-week cycles/ Participants will have 5 study visits during Cycle 1, 3 visits during Cycles 2 and 3, and 1 visit during subsequent cycles. Participants will have an End of Treatment visit 21 days (+ 7 days) after last dose of study drug and then a follow-up visit 30 days (± 7 days) after the End of Treatment visit.
Primary Outcome
Incidence of DLTs of DM001 will be determined. A dose-limiting toxicity (DLT) was defined as grade 3 neurological toxicities (e.g. chemical meningitis) or other grade 4 toxicity.
Conditions Studied
Interventions
- DRUG DM001
Study Locations (5)
Queensland
- Icon Cancer Centre South Brisbane - South Brisbane
- Tasman Oncology Research - Southport
Tennessee
- Sarah Cannon Research Institute (SCRI) - Nashville
Texas
- University of Texas MD Anderson Cancer Center - Houston
Victoria
- Monash Health - Clayton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2024-10-24 |
| Est. Completion | 2027-02-13 |
| Phase | Phase 1 |
What NCT06475937 shows while recruiting
NCT06475937 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 323-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (60% lower).
The record links to 3 conditions, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 1 intervention - of which DM001 is the first listed.
NCT06475937 lists 5 locations in 4 states (Queensland, Tennessee, Texas).
Frequently Asked Questions
What is clinical trial NCT06475937 about?
NCT06475937 is a clinical study titled "A Study of DM001 in Patients With Advanced Solid Tumors". The goal of this clinical trial is to find out about the safety, efficacy, and tolerability of DM001 for patients with the advanced solid tumors. DM001 is an experimental drug which is not approved by health authorities for the treatment of advanced solid tumors. Participants will have up to 17 vis...
What is the current status of trial NCT06475937?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 128 participants. The study started on 2024-10-24. Estimated completion is 2027-02-13.
What conditions does trial NCT06475937 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung, Breast Neoplasms, Solid Carcinoma.
What interventions are being tested in trial NCT06475937?
The interventions under investigation include: DM001 (DRUG).
Who is sponsoring clinical trial NCT06475937?
This trial is sponsored by Xadcera Biopharmaceutical (Suzhou) Co., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06475937 being conducted?
This trial has 5 study locations across Tennessee, Texas, Queensland, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06475937's enrollment target sits among peer trials
128 64th of 130 higher than 67 of 130 other Carcinoma, Non-Small Cell Lung trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Carcinoma, Non-Small Cell Lung trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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