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NCT06751329 · ClinicalTrials.gov registry record · Phase 1
A Study of DM002 in Patients With Advanced Solid Tumors
A Phase 1 study of Prostatic Neoplasms and Colorectal Neoplasms, sponsored by Xadcera Biopharmaceutical (Suzhou) Co..
- Recruiting
- Registry status
- Phase 1
- Development phase
- 160
- Enrollment target
- 5
- Study locations
NCT06751329: Recruiting Phase 1 study of Prostatic Neoplasms and Colorectal Neoplasms, sponsored by Xadcera Biopharmaceutical (Suzhou) Co..
NCT06751329 is a Phase 1 study of Prostatic Neoplasms and Colorectal Neoplasms that is actively recruiting participants, run by Xadcera Biopharmaceutical (Suzhou) Co.. The registered enrollment target is 160 participants, below the 512-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (69% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06751329, a Phase 1 study of Prostatic Neoplasms and Colorectal Neoplasms, is actively recruiting participants, sponsored by Xadcera Biopharmaceutical (Suzhou) Co..
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 160 participants
- Enrollment target
- 5
- Study locations
Study Summary
The goal of study： The study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion. In Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you. The purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers. In Part 2, participants will receive the best dose level that was determined in Part 1 of the study. The purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug. Participants will: Participants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit . Participants will be contacted by telephone every 3 months after the Follow-up visit to check on the wellbeing and record any new anticancer therapy they may have started.
Primary Outcome
Incidence of DLTs of DM002 will be determined. A dose-limiting toxicity (DLT) is defined as grade 3 neurological toxicities (e.g. chemical meningitis) or other grade 4 toxicities.
Conditions Studied
Interventions
- DRUG DM002
Study Locations (5)
New South Wales
- Scientia Clinical Research - Randwick
- Cancer Care Wollongong - Wollongong
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Texas
- The University of Texas, MD Anderson Cancer Center - Houston
South Australia
- Southern Oncology Clinical Research Unit - Adelaide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2025-02-17 |
| Est. Completion | 2028-04-18 |
| Phase | Phase 1 |
What NCT06751329 shows while recruiting
NCT06751329 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 512-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (69% lower).
The record links to 5 conditions, with Prostatic Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which DM002 is the first listed.
NCT06751329 lists 5 locations in 4 states (New South Wales, Oklahoma, Texas).
Frequently Asked Questions
What is clinical trial NCT06751329 about?
NCT06751329 is a clinical study titled "A Study of DM002 in Patients With Advanced Solid Tumors". The goal of study： The study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion. In Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There wil...
What is the current status of trial NCT06751329?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 160 participants. The study started on 2025-02-17. Estimated completion is 2028-04-18.
What conditions does trial NCT06751329 study?
This clinical trial studies the following conditions: Prostatic Neoplasms, Colorectal Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Solid Carcinoma.
What interventions are being tested in trial NCT06751329?
The interventions under investigation include: DM002 (DRUG).
Who is sponsoring clinical trial NCT06751329?
This trial is sponsored by Xadcera Biopharmaceutical (Suzhou) Co., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06751329 being conducted?
This trial has 5 study locations across Oklahoma, Texas, New South Wales, South Australia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06751329's enrollment target sits among peer trials
160 32nd of 65 higher than 34 of 65 other Prostatic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostatic Neoplasms 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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