IDH1-Mutated MalignanciesPhase 1NCT07006688
A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment
A Phase 1 study testing Ivosidenib Oral Tablet in people with IDH1-Mutated Malignancies, run by Servier Bio-Innovation LLC at 20 sites in 6 countries.
Trial summary
The objective of this study is to investigate the PK, PD, safety, and tolerability of ivosidenib in adult participants with IDH1-mutated malignancies and hepatic impairment (HI)/ renal impairment (RI). Participants will be enrolled into one of 5 groups based on their hepatic or renal function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IDH1-Mutated Malignancies
- What is being tested?
- Ivosidenib Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 20 sitesin 6 countries
- Study dates
- 14 Jan 2026to 31 Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with hematologic malignancies (including but not limited to acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myeloproliferative neoplasms, clonal cytopenia of unknown significance with a high-risk score [CHRS ≥12.5], chronic myelomonocytic leukemia, multiple myeloma, and non-Hodgkin's lymphoma) or solid tumors excluding glioma, with a locally confirmed IDH1 R132 mutation before Cycle 1 Day 1.
- Based on renal and hepatic function, participants within the:
- Moderate HI group, must have: i. Total bilirubin >1.5 to 3 × upper limit of normal (ULN), not linked to Gilbert's disease, and any aspartate aminotransferase (AST) value, ii. Adequate renal function as evidenced by creatinine clearance (CrCl) ≥60 mL/min estimated according to the Cockcroft-Gault formula. b. Severe HI group, must have: i. Total bilirubin >3 × ULN and any AST value, ii. Adequate renal function as evidenced by CrCl
- ≥60 mL/min estimated according to the Cockcroft-Gault formula. c. Severe RI group, must have: i. CrCl ≥15 to 29 mL/min estimated according to the Cockcroft-Gault formula, ii. Adequate hepatic function as evidenced by:
- Blood total bilirubin ≤1.5 × ULN, unless due to Gilbert's disease, where participants should have blood total bilirubin ≤3 × ULN;
- AST, alanine aminotransferase, and alkaline phosphatase ≤3.0 × ULN
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- Participants of the control groups with adequate hepatic or renal function characterized as:
- Hepatic control group: Adequate hepatic function as evidenced by total bilirubin and AST ≤ULN, and normal to mild RI (CrCl ≥60 mL/min estimated according to the Cockcroft-Gault formula).
- Renal control group: Adequate renal function as evidenced by CrCl ≥90 mL/min (estimated according to the Cockcroft-Gault formula) and normal to mild HI (total bilirubin ≤1.5 × ULN, participants with Gilbert's disease should have blood total bilirubin ≤3 × ULN).
- Participants previously or currently treated with ivosidenib are eligible if treated at the 500 mg QD dose or if treated at the 250 mg QD dose due to strong cytochrome P450 (CYP)3A4 inhibitor intake. Participants with a hematologic malignancy on co-treatment with azacitidine are also eligible.
- WOCBP must agree to abstain from sexual intercourse or use 2 effective methods of birth control (a highly effective method and a barrier method) from the time of giving informed consent throughout the study and for 90 days after the last dose of ivosidenib. Hormonal contraception alone is not considered an acceptable method of contraception and should be combined with a barrier method.
Who cannot join
- Have undergone hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of ivosidenib, or on immunosuppressive therapy post-HSCT at the time of screening, or with active acute or chronic graft-versus-host-disease (GVHD) requiring systemic therapy. (Participants with GVHD managed by minimal interventions [a physiologic dose of steroids] are permitted with the medical monitor's approval.)
- Have received systemic anticancer therapy (with the exception of azacitidine), investigational agent treatment, or radiotherapy <14 days, or had surgery <4 weeks before planned Cycle 1 Day 1 of ivosidenib, and/or did not recover from the AEs associated with these therapies and/or surgeries. In addition, the first dose of ivosidenib should not occur before a period of ≥5 half-lives of the study drug has elapsed.
- Have hematological diseases (other than AML or MDS) or solid tumors that are eligible for other treatments known to provide clinical benefit.
- Have received calcineurin inhibitors within 4 weeks prior to enrollment.
- Have significant active cardiac disease within 6 months before the start of ivosidenib, including NYHA Class III or IV congestive heart failure, myocardial infarction, unstable angina, and/or stroke.
- Use of any medications that are known to prolong the QT interval unless they can be transferred to other medications within ≥5 half-lives before dosing or unless the medications can be properly monitored during the study. (If equivalent medication is not available, QTcF should be closely monitored).
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- Planned use of any strong CYP3A4 inducer or sensitive CYP3A4 substrate with a narrow therapeutic window or certain antifungals that are CYP3A4 substrates while the participant is receiving ivosidenib. Participants who are taking these medications must have the minimum washout period of ≥5 half-lives before the first dose of ivosidenib and not take the medications for the duration of their participation in the study.
- Have known active inflammatory gastrointestinal disease, chronic diarrhea, previous gastric resection or laparoscopic gastric banding, short-gut syndrome, gastroparesis, or other active conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally. Gastroesophageal reflux disease under medical treatment is allowed (assuming no drug interaction potential).
- Have a known familial history of sudden death or polymorphic ventricular arrhythmia.
Trial locations and contacts
20 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department contact
20 sites in 6 countries
Spain5 sites, 5 recruiting
- Recruiting
START - Hospital HM Nou Delfos
Barcelona, 8023
- Not yet recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 8035
- Recruiting
START Madrid - Fundacion Jimenez Diaz
Madrid, 28040
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28050
- Recruiting
START Madrid Centro Oncologico Clara Campal Sanchinarro Univesrity Hospital
Madrid, 28050
Czechia4 sites, 3 recruiting
- Withdrawn
University Hospital Brno
Brno, 62500
- Recruiting
Fakultni nemocnice Ostrava
Ostrava, 70800
- Recruiting
Fakultni nemocnice v Motole FN Motol
Prague, HlavnÃ- Mesto Praha, 15000
- Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, 128 00
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
- Recruiting
Seoul National University Hospital
Seoul, 3080
- Recruiting
Severence Hospital, Yonsei University Health Systems
Seoul, 3722
- Recruiting
Asan Medical Center
Seoul, 5505
United States3 sites, 3 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
- Not yet recruiting
The Ohio State University Wexner Medical Center, The James Cancer Hospital & Solove Research Institute
Columbus, Ohio, 43210
- Recruiting
MD Anderson
Houston, Texas, 77030
Australia2 sites, 2 recruiting
- Recruiting
Royal Adelaide Hospital
Adelaide, South Australia, 5000
- Recruiting
Icon Cancer Centre
South Brisbane, Queensland, 4101
Brazil2 sites, 2 recruiting
- Recruiting
Hospital de Base de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, 15090-000
- Recruiting
Instituto do Cancer do Estado de Sao Paulo
São Paulo, 01246-000
About this study
Official title: A Phase 1, Multicenter, Open-Label, Safety and Pharmacokinetic Study of Orally Administered Ivosidenib in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment
The objective of this study is to investigate the PK, PD, safety, and tolerability of ivosidenib in adult participants with IDH1-mutated malignancies and hepatic impairment (HI)/ renal impairment (RI). Participants will be enrolled into one of 5 groups based on their hepatic or renal function. During the treatment period participants will have study visits on days 1, 4, 8, 15, 22, and 28 of Cycle 1, on days 1 and 15 of Cycle 2 and 3, and on day 1 of each additional cycle. Each cycle is 28 consecutive days of treatment and cycles will be continuous until the end of the study. Approximately 30 days after treatment has ended, a safety follow-up visit will occur. Study visits may include blood tests, ECG, vital signs, and a physical examination.
- Conditions
- IDH1-Mutated Malignancies
- Being tested
- Ivosidenib Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivosidenib Oral TabletDrug
500mg Ivosidenib taken orally once daily for continuous 28-day cycles
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Moderate Hepatic Impairment (HI) | Experimental | Not described Receives: Drug: Ivosidenib Oral Tablet |
| Group 2 - Severe HI | Experimental | Not described Receives: Drug: Ivosidenib Oral Tablet |
| Group 3 - Severe Renal Impairment (RI) | Experimental | Not described Receives: Drug: Ivosidenib Oral Tablet |
| Group 4 - Adequate hepatic function | Experimental | Not described Receives: Drug: Ivosidenib Oral Tablet |
| Group 5 - Adequate renal function | Experimental | Not described Receives: Drug: Ivosidenib Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed steady-state concentration (Cmax,ss)
Measured: Through day 28 of cycle 1
Area under the concentration time curve from 0 to 24 hours (AUC0-24hr)
Measured: Through day 28 of cycle 1
Predose plasma concentration (Ctrough)
Measured: Through day 28 of cycle 1
Time to maximum observed concentration (Tmax)
Measured: Through day 28 of cycle 1
Secondary outcomes (12)
Area under the effect concentration-time curve from time point 0 (predose) up to 8 hours postdose (AUEC0-8hr)
Measured: Through day 28 of cycle 1
Percent inhibition for AUEC0-8hr (%BAUEC0-8hr)
Measured: Through day 28 of cycle 1
Single dose ivosidenib plasma concentrations, maximum observed concentration (Cmax)
Measured: Through day 28 of cycle 1
Single dose ivosidenib plasma concentrations AUC0-24hr
Measured: Through day 28 of cycle 1
Single dose ivosidenib plasma concentrations Tmax
Measured: Through day 28 of cycle 1
Steady-state unbound ivosidenib Cmax
Measured: Day 28 of cycle 1
Steady-state unbound ivosidenib Ctrough
Measured: Day 28 of cycle 1
Steady-state unbound ivosidenib AUC0-24hr
Measured: Day 28 of cycle 1
Number of Adverse Events (AEs)
Measured: Through the Safety Follow-up Visit, 30 days after last dose (approximately 3 years)
Number of Serious Adverse Events (SAEs)
Measured: Through the Safety Follow-up Visit, 30 days after last dose (approximately 3 years)
Number of Adverse Events of Special Interest (AESIs)
Measured: Through the Safety Follow-up Visit, 30 days after last dose (approximately 3 years)
Number of AEs leading to discontinuation
Measured: Through the Safety Follow-up Visit, 30 days after last dose (approximately 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start14 Jan 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IDH1-Mutated MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Servier Bio-Innovation LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Institut de Recherches Internationales Servier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07006688
- Sponsor's protocol ID
- S095031-218
- Other IDs
- 2024-517923-38-00
- Status last verified
- Aug 2026
- First submitted
- 27 May 2025
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Multicenter, Open-Label, Safety and Pharmacokinetic Study of Orally Administered Ivosidenib in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment
- ClinicalTrials.gov ID
- NCT07006688
- Acronym / sponsor ID
- S095031-218
- Conditions
- IDH1-Mutated Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Servier Bio-Innovation LLCIndustry (pharma, biotech, devices)
- Collaborators
- Institut de Recherches Internationales Servier
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to investigate the PK, PD, safety, and tolerability of ivosidenib in adult participants with IDH1-mutated malignancies and hepatic impairment (HI)/ renal impairment (RI). Participants will be enrolled into one of 5 groups based on their hepatic or renal function. During the treatment period participants will have study visits on days 1, 4, 8, 15, 22, and 28 of Cycle 1, on days 1 and 15 of Cycle 2 and 3, and on day 1 of each additional cycle. Each cycle is 28 consecutive days of treatment and cycles will be continuous until the end of the study. Approximately 30 days after treatment has ended, a safety follow-up visit will occur. Study visits may include blood tests, ECG, vital signs, and a physical examination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Moderate Hepatic Impairment (HI) | Experimental | Drug: Ivosidenib Oral Tablet |
| Group 2 - Severe HI | Experimental | Drug: Ivosidenib Oral Tablet |
| Group 3 - Severe Renal Impairment (RI) | Experimental | Drug: Ivosidenib Oral Tablet |
| Group 4 - Adequate hepatic function | Experimental | Drug: Ivosidenib Oral Tablet |
| Group 5 - Adequate renal function | Experimental | Drug: Ivosidenib Oral Tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants with hematologic malignancies (including but not limited to acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myeloproliferative neoplasms, clonal cytopenia of unknown significance with a high-risk score [CHRS ≥12.5], chronic myelomonocytic leukemia, multiple myeloma, and non-Hodgkin's lymphoma) or solid tumors excluding glioma, with a locally confirmed IDH1 R132 mutation before Cycle 1 Day 1.
- Based on renal and hepatic function, participants within the:
- ≥60 mL/min estimated according to the Cockcroft-Gault formula. c. Severe RI group, must have: i. CrCl ≥15 to 29 mL/min estimated according to the Cockcroft-Gault formula, ii. Adequate hepatic function as evidenced by:
- Participants of the control groups with adequate hepatic or renal function characterized as:
- Participants previously or currently treated with ivosidenib are eligible if treated at the 500 mg QD dose or if treated at the 250 mg QD dose due to strong cytochrome P450 (CYP)3A4 inhibitor intake. Participants with a hematologic malignancy on co-treatment with azacitidine are also eligible.
Key exclusion criteria (9 listed)
- Have undergone hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of ivosidenib, or on immunosuppressive therapy post-HSCT at the time of screening, or with active acute or chronic graft-versus-host-disease (GVHD) requiring systemic therapy. (Participants with GVHD managed by minimal interventions [a physiologic dose of steroids] are permitted with the medical monitor's approval.)
- Have received systemic anticancer therapy (with the exception of azacitidine), investigational agent treatment, or radiotherapy <14 days, or had surgery <4 weeks before planned Cycle 1 Day 1 of ivosidenib, and/or did not recover from the AEs associated with these therapies and/or surgeries. In addition, the first dose of ivosidenib should not occur before a period of ≥5 half-lives of the study drug has elapsed.
- Have hematological diseases (other than AML or MDS) or solid tumors that are eligible for other treatments known to provide clinical benefit.
- Have received calcineurin inhibitors within 4 weeks prior to enrollment.
- Have significant active cardiac disease within 6 months before the start of ivosidenib, including NYHA Class III or IV congestive heart failure, myocardial infarction, unstable angina, and/or stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivosidenib Oral Tablet500mg Ivosidenib taken orally once daily for continuous 28-day cycles | Drug | Group 1 - Moderate Hepatic Impairment (HI), Group 2 - Severe HI, Group 3 - Severe Renal Impairment (RI), Group 4 - Adequate hepatic function, Group 5 - Adequate renal function |
Primary outcome
Maximum observed steady-state concentration (Cmax,ss)
Time frame: Through day 28 of cycle 1
Area under the concentration time curve from 0 to 24 hours (AUC0-24hr)
Time frame: Through day 28 of cycle 1
Predose plasma concentration (Ctrough)
Time frame: Through day 28 of cycle 1
Time to maximum observed concentration (Tmax)
Time frame: Through day 28 of cycle 1
12 secondary outcomes
Area under the effect concentration-time curve from time point 0 (predose) up to 8 hours postdose (AUEC0-8hr)
Time frame: Through day 28 of cycle 1
Percent inhibition for AUEC0-8hr (%BAUEC0-8hr)
Time frame: Through day 28 of cycle 1
Single dose ivosidenib plasma concentrations, maximum observed concentration (Cmax)
Time frame: Through day 28 of cycle 1
Single dose ivosidenib plasma concentrations AUC0-24hr
Time frame: Through day 28 of cycle 1
Single dose ivosidenib plasma concentrations Tmax
Time frame: Through day 28 of cycle 1
Steady-state unbound ivosidenib Cmax
Time frame: Day 28 of cycle 1
Steady-state unbound ivosidenib Ctrough
Time frame: Day 28 of cycle 1
Steady-state unbound ivosidenib AUC0-24hr
Time frame: Day 28 of cycle 1
Number of Adverse Events (AEs)
Time frame: Through the Safety Follow-up Visit, 30 days after last dose (approximately 3 years)
Number of Serious Adverse Events (SAEs)
Time frame: Through the Safety Follow-up Visit, 30 days after last dose (approximately 3 years)
Number of Adverse Events of Special Interest (AESIs)
Time frame: Through the Safety Follow-up Visit, 30 days after last dose (approximately 3 years)
Number of AEs leading to discontinuation
Time frame: Through the Safety Follow-up Visit, 30 days after last dose (approximately 3 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: Yes. Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data. Access can be requested for all interventional clinical studies: * used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope. In addition, access can be requested for all interventional clinical studies in patients: * sponsored by Servier * with a first patient enrolled as of 1 January 2004 onwards * for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department contact
20 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ivosidenib Oral Tablet in people with IDH1-Mutated Malignancies, run by Servier Bio-Innovation LLC at 20 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain, Czechia, South Korea, United States, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department (+33 1 55 72 60 00, scientificinformation@servier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed steady-state concentration (Cmax,ss) (time frame: Through day 28 of cycle 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.