Breast Cancer Clinical Trial
(VELA) Study of BLU-222 in Advanced Solid Tumors
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.
This study will include a dose-escalation phase in patients with advanced/relapsed tumors (Part 1A); platinum-resistant or platinum-refractory ovarian cancer, endometrial cancer (with prior platinum therapy) that has progressed following 2 or more lines of therapies and gastric cancer (with prior platinum therapy) that has progressed following 2 or more lines of therapies (Part 1C); and ER+ HER2- BC that has progressed despite CDK4/6i (Part 1D). This will be followed by expansion groups consisting of patients with tumors harboring specific mutation profiles: Platinum-resistant or platinum-refractory CCNE1 amplified ovarian cancer (Group 1); CCNE1 amplified endometrial cancer that has failed 2 or more lines of therapies (Group 2); CCNE1 amplified advanced/relapsed tumors that do not belong to the other groups (Group 3); ER+ HER2- BC that has progressed despite CDK4/6i (Group 4); platinum-resistant or platinum-refractory CCNE1 amplified ovarian cancer (Group 5); and ER+ HER2- BC that has progressed despite CDK4/6i (Group 6).
Advanced solid tumors that has progressed beyond standard of care OR
ER+ 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
Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.
Have received the following anticancer therapy:
a. Previous therapy with CDK2i, PKMYT1i, or WEE1i, except in Part 1A where up to 10 patients who previously received PKMYT1i, or WEE1 inhibitor will be permitted.
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, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome.
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).
Have a history of another primary malignancy other than completely resected carcinomas in situ) that has been diagnosed or required therapy within 2 years prior to initiation of study treatment.
Have active, uncontrolled infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B virus (HBV), hepatitis C virus, AIDS-related illness, or COVID-19 infection (symptoms and a positive test result).
Requires treatment with a prohibited medication or herbal remedy that cannot be discontinued at least 2 weeks before the start of study drug administration.
Have planned major surgical procedure within 14 days of the first dose of study drug (procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures).
Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions.
Patient is a woman who is not postmenopausal or surgically sterile, and is unwilling to abstain from sexual intercourse or employ highly effective contraception OR is a man who is not surgically sterile, and is unwilling to abstain from sexual intercourse or employ highly effective contraception
Patient is a pregnant female
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There are 5 Locations for this study
Sarasota Florida, 34232, United States
Boston Massachusetts, 02114, United States
New York New York, 10032, United States
Houston Texas, 77030, United States
Charlottesville Virginia, 22903, United States
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