New study checks how liver issues affect cancer drug pelabresib
NCT ID NCT07422610
First seen Jun 25, 2026 · Last updated Sep 18, 2026 · Updated 6 times
Summary
This early-phase study is testing the cancer drug pelabresib in 24 people with advanced cancers who also have liver problems. The goal is to see how the liver affects the drug levels in the body. Participants will take the drug daily for 14 days, then have a week off. This research aims to find the right dose for patients with liver impairment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pelabresib
- What this could lead to
- If successful, this study could help doctors determine the right dose of pelabresib for patients with liver problems, potentially making treatment safer and more effective.
- What could go wrong
- This is a very early, small study (24 people) focused on drug levels, not on curing cancer. It may not lead to any new treatments, and liver impairment could increase side effects.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Aug 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Key Inclusion Criteria: * Is at least 18 and not older than 75 years of age at the time of signing the informed consent. * Group 1 only: There is a matching participant in Group 2 and an enrollment slot is available for the Group 1 participant. * Has a confirmed documented diagnosis of an advanced malignancy for which no standard and/or curative treatment options are available. * Has the following acceptable laboratory assessments prior to the first dose of study treatment: 1. Platelet count ≥ 150 × 109 /L in the absence of thrombopoietic factors or transfusions within 2 weeks of the screening assessment 2. Absolute neutrophil count (ANC) ≥ 1 × 109 /L in the absence of granulocyte growth factors 3. Adequate renal function (creatinine clearance of ≥30 mL/min, calculated using Cockcroft-Gault formula) 4. Peripheral blood blast count \< 5%. Assessment of blasts in bone marrow is not mandatory at screening, however, blasts must be \<5% if the assessment is performed. * Has a life expectancy ≥3 months. * Has fully recovered from major surgery and from the acute toxic effects of prior chemotherapy and radiotherapy . * Hepatic function: 1. Is in Group 1 and is classified as having normal hepatic function based on NCI-ODWG criteria (i.e., total bilirubin ≤ upper limit of normal (ULN) and aspartate aminotransferase (AST) ≤ ULN); or 2. Is in Group 2 and has stable moderate or severe HI as defined by NCI ODWG criteria: * moderate HI: total bilirubin \>1.5 × to 3 × ULN, and any AST value * severe HI: total bilirubin \> 3 × ULN, and any AST value Key Exclusion Criteria: * Has a history of hypersensitivity to the study treatment or its excipients or to drugs of similar chemical class. * Has any other medical condition which, in the investigator's opinion, makes the participant unsuitable for the study. * Is a female participant who is pregnant (confirmed by a pregnancy test at screening) or is breastfeeding. * Is a woman of childbearing potential (WOCBP) who does not agree to follow the contraceptive guidance during the treatment period and for at least 184 days after the last dose of study treatment, and who does not agree to refrain from donating eggs during this period. * Has esophageal variceal bleeding within the past 2 months prior to the first dose of pelabresib. * Has an active clinically significant infection. * Has impaired cardiac function or clinically significant cardiac diseases * Has a GI tumor, impaired GI function, GI disease, or significant resection of stomach or other portion of the GI tract that could alter the absorption of pelabresib, including any unresolved nausea, vomiting, or diarrhea. Other protocol-defined inclusion/exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites in 4 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Novartis Investigative Site
RECRUITINGBordeaux, 33075, France
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Novartis Investigative Site
RECRUITINGSaint-Herblain, 44805, France
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Novartis Investigative Site
RECRUITINGMilan, MI, 20132, Italy
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Novartis Investigative Site
RECRUITINGMilan, MI, 20141, Italy
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Novartis Investigative Site
RECRUITINGCandiolo, TO, 10060, Italy
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Novartis Investigative Site
RECRUITINGPozuelo de Alarcón, Madrid, 28223, Spain
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Novartis Investigative Site
RECRUITINGBarcelona, 08023, Spain
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Novartis Investigative Site
RECRUITINGMadrid, 28040, Spain
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Novartis Investigative Site
RECRUITINGMadrid, 28050, Spain
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Novartis Investigative Site
RECRUITINGLondon, W12 0HS, United Kingdom
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