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(VELA) Study of BLU-222 in Advanced Solid Tumors
EU CTIS ID: 2022-502528-29-00
What this study is testing
Phase 1: To determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of BLU-222 monotherapy and in combination with carboplatin or ribociclib and fulvestrant. To evaluate the safety and tolerability of BLU-222 monotherapy and in combination with carboplatin or ribociclib and fulvestrant. Phase 2 : To assess the anticancer activity of BLU-222 at the RP2D in patients with advanced solid tumors, as a monotherapy and in combination with carboplatin, fulvestrant, or ribociclib and fulvestrant. To evaluate the safety and tolerability of BLU222 monotherapy and in combination with carboplatin, fulvestrant, or ribociclib and fulvestrant
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1)Advanced solid tumors that has progressed beyond standard of care OR 2)HR+ HER2- BC that has progressed following treatment with a CDK4/6 inhibitor OR 3)Endometrial and gastric cancer that has progressed after at least 2 prior therapies (including one prior platinum therapy) OR 4)Platinum refractory or platinum resistant ovarian cancer 5)CCNE1 amplified tumors that have progressed beyond standard of care
You likely can't join if
- 1. Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.
- 10. Have active, uncontrolled infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B virus (HBV), hepatitis C virus, AIDSrelated illness, or COVID-19 infection (symptoms and a positive test result).
- 11. Requires treatment with a prohibited medication or herbal remedy that cannot be discontinued at least 2 weeks before the start of study drug administration.
- 12. 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).
- 13. Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions.
- 14. 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
See the full eligibility criteria
- 1)Advanced solid tumors that has progressed beyond standard of care OR 2)HR+ HER2- BC that has progressed following treatment with a CDK4/6 inhibitor OR 3)Endometrial and gastric cancer that has progressed after at least 2 prior therapies (including one prior platinum therapy) OR 4)Platinum refractory or platinum resistant ovarian cancer 5)CCNE1 amplified tumors that have progressed beyond standard of care
- 1. Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.
- 10. Have active, uncontrolled infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B virus (HBV), hepatitis C virus, AIDSrelated illness, or COVID-19 infection (symptoms and a positive test result).
- 11. Requires treatment with a prohibited medication or herbal remedy that cannot be discontinued at least 2 weeks before the start of study drug administration.
- 12. 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).
- 13. Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions.
- 14. 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
- 15. Patient is a pregnant female
- 2. 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.
- 3. 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.
- 4. Have known intracranial hemorrhage and/or bleeding diatheses.
- 5. Have clinically active ongoing ILD of any etiology, including drug induced ILD, and radiation pneumonitis within 28 days prior to initiation of study treatment.
- 6. 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.
- 7. Have mean resting QTcF > 450 msec, a history of prolonged QT syndrome or Torsades de pointes, or a familial history of prolonged QT syndrome.
- 8. Have clinically significant, uncontrolled, cardiovascular diseaseincluding 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 thirddegree heart block).
- 9. 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- United States
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; United States; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.