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NCT05768932 · ClinicalTrials.gov registry record · Phase 1
BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study of Advanced Solid Tumor and Gastric Cancer, sponsored by SillaJen.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 260
- Enrollment target
- 12
- Study locations
NCT05768932: Recruiting Phase 1 study of Advanced Solid Tumor and Gastric Cancer, sponsored by SillaJen.
NCT05768932 is a Phase 1 study of Advanced Solid Tumor and Gastric Cancer that is actively recruiting participants, run by SillaJen. The registered enrollment target is 260 participants, above the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (35% higher). The trial reports 12 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05768932, a Phase 1 study of Advanced Solid Tumor and Gastric Cancer, is actively recruiting participants, sponsored by SillaJen.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 260 participants
- Enrollment target
- 12
- Study locations
Study Summary
This study is a multiple cohort, multicenter, open-label Phase 1 study with dose-escalation substudies investigating intravenous (IV) BAL0891 as monotherapy, and in combination with tislelizumab or paclitaxel, to determine the safety and tolerability of increasing doses of BAL0891 in patients with advanced solid tumors or relapsed or refractory acute myeloid leukemia. An adaptive model-based design will be used to guide the dose escalation. Subject assignment to Substudy 1, 2, 3 and 4 will be finalized following approval from the investigator and sponsor. The dose-expansion stage will be conducted with the RP2D to further evaluate the preliminary anti-tumor activity, safety, and tolerability in metastatic TNBC and GC.
Primary Outcome
Safety is collected through summaries of AE(Adverse Event)s, safety laboratory evaluations, PK evaluations, physical examinations, vital signs, and ECGs using CTCAE v5.0.
Conditions Studied
Interventions
- DRUG BAL0891
- COMBINATION_PRODUCT Tislelizumab
- COMBINATION_PRODUCT Paclitaxel
Study Locations (12)
Other
- The Catholic University of Korea, Seoul St. Mary's Hospital - Seoul
- Asan Medical Center - Seoul
- Korean University Anam Hospital - Seoul
- Samsung Medical Center - Seoul
- Seoul National University Hospital - Seoul
- Severance Hospital, Yonsei University Health System - Seoul
Texas
- Mary Crowley Cancer Research - Dallas
- The University of Texas MD Anderson Cancer Center - Houston
Connecticut
- Yale New Haven Hospital - New Haven
Florida
- University of Miami Health System - Coral Gables
New York
- Montefiore Medical Center - The Bronx
Oregon
- OHSU Knight Cancer Institute - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2022-12-14 |
| Est. Completion | 2026-12-24 |
| Phase | Phase 1 |
What NCT05768932 shows while recruiting
NCT05768932 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, above the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (35% higher).
The record links to 4 conditions, with Advanced Solid Tumor appearing as the primary indexed condition, and to 3 interventions - of which BAL0891 is the first listed.
NCT05768932 lists 12 locations in 6 states (Other, Texas, Connecticut).
Frequently Asked Questions
What is clinical trial NCT05768932 about?
NCT05768932 is a clinical study titled "BAL0891 in Patients With Advanced Solid Tumors or Relapsed or Refractory Acute Myeloid Leukemia". This study is a multiple cohort, multicenter, open-label Phase 1 study with dose-escalation substudies investigating intravenous (IV) BAL0891 as monotherapy, and in combination with tislelizumab or paclitaxel, to determine the safety and tolerability of increasing doses of BAL0891 in patients with a...
What is the current status of trial NCT05768932?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 260 participants. The study started on 2022-12-14. Estimated completion is 2026-12-24.
What conditions does trial NCT05768932 study?
This clinical trial studies the following conditions: Advanced Solid Tumor, Gastric Cancer, TNBC - Triple-Negative Breast Cancer, Leukemia Acute Myeloid Leukemia (AML).
What interventions are being tested in trial NCT05768932?
The interventions under investigation include: BAL0891 (DRUG), Tislelizumab (COMBINATION_PRODUCT), Paclitaxel (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05768932?
This trial is sponsored by SillaJen, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05768932 being conducted?
This trial has 12 study locations across Connecticut, Florida, New York, Oregon, Texas. 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 NCT05768932's enrollment target sits among peer trials
260 42nd of 189 higher than 148 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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