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Cancer drug safety tracked in ongoing rollover trial

NCT ID NCT06788509

Disease control Sponsor: Janssen Research & Development, LLC 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 28, 2026 · Updated 5 times

Summary

This study monitors long-term safety in 120 cancer patients who are already benefiting from treatments like JNJ-75348780, safimaltib, or ibrutinib in earlier trials. Participants have blood cancers, solid tumors, or prostate cancer. The goal is to track serious side effects over time.

What this could mean

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

Active substance
JNJ-75348780, safimaltib, and ibrutinib
What this could lead to
If successful, this study will confirm the long-term safety of these cancer drugs, supporting their continued use in patients who benefit.
What could go wrong
This is an early-phase rollover study focused on safety, not efficacy. It enrolls only patients already benefiting, so results may not apply to all. Side effects remain possible.

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

About 120 people

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

Started

Dec 2024

Expected to finish

Oct 2028

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: * Have participated in a parent study, with a linked intervention specific appendix (ISA) within this platform study, in which they initially received study treatment(s) prior to rolling over to this platform study * Satisfy all ISA specific inclusion criteria * Sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the platform study with details per the relevant ISA * Be willing and able to adhere to the lifestyle restrictions specified in the relevant ISA Exclusion Criteria: * Have any condition or situation which, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject's participation in the study * Have unacceptable toxicities or overt disease progression observed at time of rollover to the respective ISA * Meets any exclusion criteria within the pertinent ISA

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Conditions

The condition(s) this trial relates to.

acute myeloid leukemia B-cell chronic lymphocytic leukemia castration-resistant prostate carcinoma lymphoma, non-Hodgkin, familial metastatic prostate carcinoma myelodysplastic syndrome Myelodysplastic Syndromes neoplasm non-Hodgkin lymphoma Prostatic Neoplasms, Castration-Resistant

As listed by the trial registrant

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

Leukemia, lymphocytic, chronic, B-cell Leukemia, myeloid, acute Lymphoma, non-Hodgkin Metastatic castration-resistant prostate cancer (MCRPC) Myelodysplastic syndromes Neoplasms Prostatic neoplasms, castration-resistant Solid tumor, adult

How to take part

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

  1. The places running it

    38 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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

Locations

  • Aidport Sp z o o

    Skorzewo, 60-185, Poland

  • Alexandra Hospital

    Athens, 115 28, Greece

  • Arensia Exploratory Medicine

    Tbilisi, Postal code 0112, Georgia

  • Arensia Exploratory Medicine

    Chisinau, 2025, Moldova

  • CHU Nantes

    Nantes, 44093, France

  • Carmel Medical Center

    Haifa, 3436212, Israel

  • Chang Kung Memorial Hospital

    Kaohsiung City, 833, Taiwan

  • China Medical University Hospital

    Taichung, 404327, Taiwan

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Dep. of Hematology, Rigshospitalet

    Copenhagen, 2100, Denmark

  • Ghent University Hospital

    Ghent, 9000, Belgium

  • Hadassah University Hospita Ein Kerem

    Jerusalem, 9112001, Israel

  • Hopital Claude Huriez

    Lille, 59000, France

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp Univ Vall D Hebron 1

    Barcelona, 08035, Spain

  • Hosp. Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Linear Clinical Research Ltd

    Nedlands, 6009, Australia

  • Macquarie University Hospital

    Macquarie University, 2109, Australia

  • Medical Center of Limited Liability Company Arensia Exploratory Medicine

    Kyiv, 01135, Ukraine

  • National Cheng Kung University Hospital

    Tainan, 704, Taiwan

  • National Hospital Organization Nagoya Medical Center

    Nagoya, 460-0001, Japan

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • Odense Universitetshospital

    Odense C, DK-5000, Denmark

  • Pratia MCM Krakow

    Krakow, 30-727, Poland

  • Rambam Med.Center - Hematology Institute

    Haifa, 3109601, Israel

  • Rambam Medical Center

    Haifa, 3109601, Israel

  • Scientia Clinical Research

    Randwick, 2031, Australia

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • St Bartholomews Hospital

    London, EC1A 7BE, United Kingdom

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • The Cancer Institute Hospital of JFCR

    Tokyo, 135 8550, Japan

  • University Hospitals Of Leicester Nhs Trust

    Leicester, Le1 5ww, United Kingdom

  • University Hospitals Plymouth NHS Trust

    Plymouth, PL6 8DH, United Kingdom

  • Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz

    Gdansk, 80 214, Poland

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