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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05768932
The ClinicalTrials.gov registry entry for NCT05768932 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 192-participant average among 189 other Advanced Solid Tumor trials with a reported enrollment target (35% higher). The listed sponsor is SillaJen, which has 3 total studies on file at ClinicalTrials.gov.
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 reports 12 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Related
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