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NCT06566079 · ClinicalTrials.gov registry record · Phase 1
Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors
A Phase 1 study of Advanced Solid Tumor and Malignant Mesothelioma, sponsored by InSilico Medicine Hong Kong Limited.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
- 10
- Study locations
NCT06566079: Recruiting Phase 1 study of Advanced Solid Tumor and Malignant Mesothelioma, sponsored by InSilico Medicine Hong Kong Limited.
NCT06566079 is a Phase 1 study of Advanced Solid Tumor and Malignant Mesothelioma that is actively recruiting participants, run by InSilico Medicine Hong Kong Limited. The registered enrollment target is 100 participants, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (48% lower). The trial reports 10 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06566079, a Phase 1 study of Advanced Solid Tumor and Malignant Mesothelioma, is actively recruiting participants, sponsored by InSilico Medicine Hong Kong Limited.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
- 10
- Study locations
Study Summary
This is a Phase 1, open-label, multicenter, FIH study to evaluate the safety, tolerability, recommended Phase 2 dose (RP2D), PK/PD, and preliminary anti-tumor activity of ISM6331 in participants with advanced or metastatic malignant mesothelioma or other solid tumors. The study consists of two parts, a dose escalation part (Part 1) and a dose selection optimization part (Part 2).
Primary Outcome
DLT is defined as any adverse event which meets DLT criteria unless it is clearly related to disease progression or intercurrent illness during the first 31 days after the initiation of treatment in the dose escalation part (Part 1).
Conditions Studied
Interventions
- DRUG ISM6331
Study Locations (10)
Other
- Cancer Hospital Chinese Academy of Medical Sciences - Beijing
- Sun Yat-Sen University Cancer Center - Guangzhou
Colorado
- Sarah Cannon Research Institute at HealthONE - Denver
Illinois
- The University of Chicago Medical Center - Duchossois Center for Advanced Medicine - Chicago
Ohio
- University Hospitals Cleveland Medical Center - Cleveland
Pennsylvania
- University of Pennsylvania - Abramson Cancer Center - Philadelphia
Tennessee
- SCRI Oncology Partners - Nashville
Texas
- NEXT Oncology - Austin - Austin
Henan
- Henan Cancer Hospital - Zhengzhou
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-12-27 |
| Est. Completion | 2028-02-28 |
| Phase | Phase 1 |
What NCT06566079 shows while recruiting
NCT06566079 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (48% lower).
The record links to 3 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which ISM6331 is the first listed.
NCT06566079 lists 10 locations in 9 states (Other, Colorado, Illinois).
Frequently Asked Questions
What is clinical trial NCT06566079 about?
NCT06566079 is a clinical study titled "Study of ISM6331 in Participants With Advanced/Metastatic Malignant Mesothelioma or Other Solid Tumors". This is a Phase 1, open-label, multicenter, FIH study to evaluate the safety, tolerability, recommended Phase 2 dose (RP2D), PK/PD, and preliminary anti-tumor activity of ISM6331 in participants with advanced or metastatic malignant mesothelioma or other solid tumors. The study consists of two parts...
What is the current status of trial NCT06566079?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2024-12-27. Estimated completion is 2028-02-28.
What conditions does trial NCT06566079 study?
This clinical trial studies the following conditions: Advanced Solid Tumor, Malignant Mesothelioma, Metastatic Malignant Solid Tumor.
What interventions are being tested in trial NCT06566079?
The interventions under investigation include: ISM6331 (DRUG).
Who is sponsoring clinical trial NCT06566079?
This trial is sponsored by InSilico Medicine Hong Kong Limited, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06566079 being conducted?
This trial has 10 study locations across Colorado, Illinois, Ohio, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06566079's enrollment target sits among peer trials
100 116th of 189 higher than 73 of 189 other Advanced Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced Solid Tumor 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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