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New pill combo shows promise for tough brain cancer

NCT ID NCT03328078

Disease control Sponsor: Curis, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an experimental oral drug called emavusertib (CA-4948), taken alone or with ibrutinib, in adults with relapsed or refractory primary central nervous system lymphoma (PCNSL). The trial has multiple parts to find the safest dose and see if the drug shrinks tumors. About 152 participants will be enrolled across several centers.

What this could mean

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

Active substance
Emavusertib (also called CA-4948) taken as a tablet, alone or with another drug called ibrutinib.
What this could lead to
If successful, this could offer a new oral treatment option for patients with a hard-to-treat brain lymphoma that has come back or not responded to other therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not work as hoped or could have serious side effects. It is not yet proven to be safe or effective.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 152 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2017

Expected to finish

Oct 2026

An estimate. End dates often move.

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. Males and females greater than or equal to 18 years of age 2. Life expectancy of at least 3 months 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2 4. Histopathologically confirmed diagnosis of PCNSL (medical record is acceptable). Cerebral biopsies are not required if imaging reveals typical images of PCNSL. 1. Participants with parenchymal lesions must have unequivocal evidence of disease progression (e.g., presence of at least 1 measurable target lesion \[≥ 10 millimeters (mm) and ≤ 40 mm in the longest diameter on brain magnetic resonance imaging \[MRI\] or head computed tomography \[CT\] on imaging within 28 days prior to Cycle 1 Day 1\]). In cases where the tumor size is smaller but still measurable and located at a critical central nervous system (CNS) location, disabling the participant and/or causing symptoms, this participant may be eligible following a discussion with the Sponsor Medical Monitor. 2. For participants limited to leptomeningeal involvement, cerebrospinal fluid (CSF) analysis (cytology and/or flow cytometry) with or without additional imaging (MRI) of the spine as clinically indicated is required to document abnormal cells within 28 days prior to Cycle 1 Day 1. Exclusion Criteria for Part B and Part C 1. Participants with only intraocular PCNSL without brain lesion or CSF involvement, T-cell lymphoma, systemic presence of lymphoma, or non-CNS lymphoma metastatic to the CNS 2. Evidence of systemic lymphoma. This must be demonstrated by a positron emission tomography (PET) scan (or CT scan with contrast if applicable) of the chest, abdomen, and pelvis at Screening (testicular ultrasound may be considered to exclude a testicular lymphoma disseminated to the brain). 3. Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast) or prior history of systemic lymphoma, unless the participant has been free of the disease for ≥ 3 years. 4. Active malignancy other than PCNSL requiring systemic therapy 5. Previous BTKi treatment (Part C only). 6. History of Grade ≥ 3 rhabdomyolysis without complete recovery 7. Requirement for urgent therapy due to uncontrolled tumor mass/edema effects. 8. Received external beam radiation therapy to the CNS within 28 days prior to Cycle 1 Day 1. 9. Received prior investigational drugs (including treatment in clinical research, unapproved combination products, and new dosage forms) within 28 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1; allogeneic hematopoietic stem cell transplant (HSCT) within 60 days prior to Cycle 1 Day 1; or had clinically significant graft-versus-host disease (GVHD) requiring ongoing up-titration of immunosuppressive medications prior to Screening (with the exception of a BTKi for Part B only). Note: The use of a stable or tapering dose of immunosuppressive therapy post-HSCT and/or topical steroids for ongoing skin GVHD is permitted with Sponsor Medical Monitor approval 10. Any prior systemic anti-cancer treatment such as chemotherapy, immunomodulatory drug therapy, etc., received within 14 days or 5 half-lives, whichever is shorter, prior to Cycle 1 Day 1 (with the exception of ibrutinib or other BTKi for Part B only, which may be continued until the day before Cycle 1 Day 1) 11. Prior history of hypersensitivity or anaphylaxis to emavusertib, ibrutinib or any of their excipients.

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid system neoplasm immune system disorder immunoproliferative disorder lymphatic system disorder lymphoma lymphoproliferative syndrome neoplasm non-Hodgkin lymphoma primary central nervous system lymphoma Recurrence refractory hematologic cancer

As listed by the trial registrant

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

Refractory hematologic malignancy Refractory primary central nervous system lymphoma Relapsed hematologic malignancy Relapsed primary central nervous system lymphoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    35 sites in 7 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Columbia University Irving Medical Center

    WITHDRAWN

    New York, New York, 10032, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke University Medical Center, Duke Cancer Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fred and Pamela Buffett Cancer Center

    RECRUITING

    Omaha, Nebraska, 68198, United States

  • Hackensack University Medical Center

    COMPLETED

    Hackensack, New Jersey, 07601, United States

  • Hadassah Medical Center / Ein-Carem

    RECRUITING

    Jerusalem, Israel

  • Hematology Department Soroka UMC / Heanatology Department

    RECRUITING

    Beersheba, Israel

  • Hopital de la Timone

    RECRUITING

    Marseille, France

  • Hospital Pitie Salpetriere

    RECRUITING

    Paris, France

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, Spain

  • Hospital of the University of Pennsylvania

    COMPLETED

    Philadelphia, Pennsylvania, 19104, United States

  • Huntsman Cancer Institute, University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • IRCCS San Raffaele Scientific Institute

    RECRUITING

    Milan, Italy

  • IRST - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    RECRUITING

    Meldola, Italy

  • Institut Bergonie

    RECRUITING

    Bordeaux, France

  • Institut Curie Hospital

    RECRUITING

    Paris, France

  • MD Anderson Cancer Center Madrid

    RECRUITING

    Madrid, Spain

  • Mayo Clinic

    COMPLETED

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Mt Sinai

    RECRUITING

    New York, New York, 10029, United States

  • NarodowyInstytutu Onkologii im. Marii Sklodowskiej-Curie-Panstwowy Instytutu Badawczy

    RECRUITING

    Warsaw, Poland

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Oddzial Kliniczny Hematologii

    WITHDRAWN

    Krakow, Poland

  • Providence Neurological Specialties West

    RECRUITING

    Portland, Oregon, 97225, United States

  • Providence St. John's Health Center

    RECRUITING

    Santa Monica, California, 90404, United States

  • Rambam Medical Center

    RECRUITING

    Haifa, Israel

  • Roswell Park Comprehensive Cancer Center

    RECRUITING

    Buffalo, New York, 14263, United States

  • SODc Ematologia Azienda Ospedaliera Universitaria Careggi

    RECRUITING

    Florence, Italy

  • Smilow Cancer Hospital at Yale-New Haven

    COMPLETED

    New Haven, Connecticut, 06510, United States

  • St. Joseph's Hospital and Medical Center

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • Swedish Cancer Institute

    COMPLETED

    Seattle, Washington, 98104, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UCLA Department of Medicine - Hematology/Oncology

    WITHDRAWN

    Santa Monica, California, 90404, United States

  • UPMC Hilman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • UT Southwestern Medical Center

    ACTIVE_NOT_RECRUITING

    Dallas, Texas, 75235, United States

  • University Hospital Vall d'Hebron

    RECRUITING

    Barcelona, Spain

  • University of Tennessee Medical Center

    COMPLETED

    Knoxville, Tennessee, 37920, United States

  • University of Washington Medical Center

    RECRUITING

    Seattle, Washington, 98195, United States

  • Università di Torino Croce e Carle

    RECRUITING

    Cuneo, Italy

  • Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz

    RECRUITING

    Gdansk, Poland

  • Všeobecná fakultní nemocnice v Praze

    RECRUITING

    Prague, Czechia

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