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NCT07006688
A Study of an IDH1m Inhibitor in Participants With IDH1-Mutated Malignancies and Hepatic or Renal Impairment
Phase 1 trial testing Ivosidenib Oral Tablet in IDH1-Mutated Malignancies in 30 participants. Currently enrolling.
31 July 2028
Quick facts
| Lead sponsor | Servier Bio-Innovation LLC |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 14 January 2026 |
| Primary completion | 31 July 2028 |
| Estimated completion | 31 August 2028 |
| Sites | 19 locations across South Korea, Australia, Spain, United States, Brazil, Czechia |
Drugs / interventions tested
- Ivosidenib Oral Tablet — full drug profile →
Conditions studied
- IDH1-Mutated Malignancies — all drugs for IDH1-Mutated Malignancies →
Sponsor
Servier Bio-Innovation LLC — full company profile →
Who can join
18 and older, any sex, with IDH1-Mutated Malignancies. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Targeting tumor dormancy: the next frontier in gastrointestinal stromal tumor therapy.
Wu S, Liu H, Yin Y, Li J, et al · · 2026 · PMID 41955967 · DOI 10.1016/j.neo.2026.101306
Verify or expand the search:
- PubMed search for NCT07006688
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ivosidenib Oral Tablet
Trials testing the same drug.
- NCT05876754 — An Early Access Study of Ivosidenib in Patients With a Pretreated Locally Advanced or Metastatic Cholangiocarcinoma · Phase 3 · recruiting
Other recruiting trials for IDH1-Mutated Malignancies
Currently open trials in the same condition.
- NCT07032727 — Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Act · Phase 2 · recruiting
Other Servier Bio-Innovation LLC trials
Trials by the same sponsor.
- NCT06563804 — A Study to Evaluate S227928 as a Single Agent and in Combination With Venetoclax in Patients With R/R AML, MDS/AML, or C · Phase 1, PHASE2 · terminated
- NCT06127407 — Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treat · Phase 3 · recruiting
- NCT06188702 — S095035 as a Single Agent and in Combination in Adult Participants With Advanced or Metastatic Solid Tumors With Deletio · Phase 1, PHASE2 · recruiting
- NCT05921760 — Ivosidenib, Nivolumab, and Ipilimumab Combination in Previously Treated Subjects With Nonresectable or Metastatic IDH1 M · Phase 1, PHASE2 · terminated
- NCT05843708 — A Phase 1, Open-Label Study to Evaluate the Effect of a Low-Fat Meal and Multiple Doses of Ciprofloxacin on the Pharmaco · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07006688 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Servier Bio-Innovation LLC
- Last refreshed: 6 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07006688.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing