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New cancer drug BLU-222 tested in early trial – but study stopped early

NCT ID NCT05252416

Disease control Sponsor: Blueprint Medicines Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested a new drug called BLU-222, alone or with other medicines, in about 50 people with advanced solid tumors (including certain breast, ovarian, and stomach cancers). The goal was to find a safe dose and see if it shrinks tumors. However, the study was terminated early, so full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BLU-222 (a CDK2 inhibitor drug taken by mouth)
What this could lead to
If it works, this could point toward a new treatment option for certain advanced cancers, especially those with CCNE1 amplification.
What could go wrong
This is a very early (Phase 1/2) trial that was terminated, so results are limited. The drug may not be effective or safe in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

50 people

The number who actually took part.

Started

Apr 2022

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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 CCNE1 amplified tumors that have progressed beyond standard of care Exclusion Criteria: 1. Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis. 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 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. 8. 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). 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. 10. Have known 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). 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

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus carcinosarcoma endometrial cancer endometrium neoplasm esophageal adenocarcinoma gastric cancer gastric neoplasm Her2-receptor negative breast cancer hormone receptor-positive breast cancer neoplasm ovarian cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors Carcinosarcoma CCNE1 amplification Endometrial cancer Esophageal adenocarcinoma Gastric cancer HER2-negative breast cancer HR+ breast cancer Ovarian cancer

Contacts and locations

Locations

  • Columbia University Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Florida Cancer Specialists

    Sarasota, Florida, 34232, United States

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario A Gemelli-Rome

    Rome, 00168, Italy

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hospital of the Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111, United States

  • Instituto Europeo di Oncologia

    Milan, 20141, Italy

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (SKCCC)

    Baltimore, Maryland, 21287, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Montefiore Medical Center

    New York, New York, 10461, United States

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • St Bartholomew's Hospital

    London, Middlesex, EC1A 7BE, United Kingdom

  • Stanford Women's Cancer Center

    Stanford, California, 94305, United States

  • UCSF Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158, United States

  • UNC Hospitals at Chapel Hill - The University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Utah - Huntsman Cancer Institute - PPDS

    Salt Lake City, Utah, 84112, United States

  • University of Virginia Comprehensive Cancer Center

    Charlottesville, Virginia, 22903, United States

  • Vanderbilt Breast Center at One Hundred Oaks

    Nashville, Tennessee, 37204, United States

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