(VELA) Study of BLU-222 in Advanced Solid Tumors (NCT05252416) | Clinical Trial Compass
TerminatedPhase 1
(VELA) Study of BLU-222 in Advanced Solid Tumors
Stopped: This trial was terminated prior to the initiation of Phase 2 for reasons not due to safety concerns.
United States50 participantsStarted 2022-04-07
Plain-language summary
This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-222, a selective inhibitor of CDK2.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Advanced solid tumors that has progressed beyond standard of care OR
✓. HR+ HER2- BC that has progressed following treatment with a CDK4/6 inhibitor OR
✓. Endometrial and gastric cancer that has progressed after at least 2 prior therapies (including one prior platinum therapy) OR
✓. Platinum refractory or platinum resistant ovarian cancer CCNE1 amplified tumors that have progressed beyond standard of care
Exclusion criteria
✕. Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.
✕. Have received the following anticancer therapy:
✕. Have central nervous system (CNS) metastases or spinal cord compression that is associated with progressive neurological symptoms or requires increasing doses of corticosteroids to control the CNS disease.
✕. Have known intracranial hemorrhage and/or bleeding diatheses.
✕. Have clinically active ongoing ILD of any etiology, including drug-induced ILD, and radiation pneumonitis within 28 days prior to initiation of study treatment.
✕. Have any unresolved toxicities from prior therapy greater than CTCAE Grade 1 or that have not resolved to baseline at the time of starting the study.
✕. Have mean resting QTcF \> 450 msec in men or QTcF \> 470 msec in women, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome.
What they're measuring
1
[Phase 1] Determine the maximum tolerated dose (MTD) of BLU-222
Timeframe: Approximately 21 months
2
[Phase 1] Determine the recommended Phase 2 dose (RP2D) of BLU-222
✕. Have clinically significant, uncontrolled, cardiovascular disease including congestive heart failure Grade III or IV according to the New York Heart Association classification; myocardial infarction or unstable angina within the previous 6 months, uncontrolled hypertension, or clinically significant, uncontrolled arrhythmias, including bradyarrhythmia that may cause QT prolongation (eg, Type II second degree heart block or third-degree heart block).