Clinical trial · Interventional
A Study of HMPL-306 in Advanced Solid Tumors With IDH Mutations
A Multicenter, Open-Label, Phase I Study Evaluating the Safety and Tolerability of HMPL-306 in Subjects With Locally Advanced or Metastatic Solid Tumors With IDH Mutations
NCT04762602CI-TRIAL-00106531terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was terminated based on strategic evaluation of the clinical development of HMPL-306 with no safety concerns
Summary
Brief summary (as posted)
An open label single-arm clinical trial to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of HMPL-306 in advanced or metastatic solid tumors with IDH mutation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Isocitrate Dehydrogenase Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HMPL-306 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Part 1 Dose Escalation Cohorts
- description
- Patients from each cohort will be administered HMPL-306 orally QD
- interventionNames
- Drug: HMPL-306
- type
- EXPERIMENTAL
- label
- Part 2 Dose Expansion Cohorts
- description
- Patients from each cohort will be administered HMPL-306 orally QD at the recommended phase 2 dose
- interventionNames
- Drug: HMPL-306
Primary outcomes (3)
- measure
- Part 1: Recommended Phase 2 Dose (RP2D) of HMPL-306
- timeFrame
- From the first dose of study drug (Day 1) up to Day 28 of Cycle 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: Subjects are eligible for enrollment into this study if they meet any of the following criteria (NOTE: This is not an exhaustive list): * Subjects aged ≥18 years. * ECOG performance status 0 or 1 * Subjects must have a documented IDH mutation per immunohistochemistry (IHC), polymerase chain reaction (PCR), or next generation sequencing (NGS) testing of tumor tissue. * Subjects must have histologically or cytologically documented, advanced or metastatic solid malignancy of any type that has recurred or progressed on available standard treatment and for which no curative therapy exists. Key Exclusion Criteria: Subjects are not eligible for enrollment into this study if they meet any of the following criteria (NOTE: This is not an exhaustive list): * Subjects who received an investigational agent \<14 days prior to their first day of study drug administration * Subjects who are pregnant or breastfeeding * Subjects with an active severe infection, some treated infections and with an expected or with an unexplained fever \>38.3°C during screening visits or on their first day of study drug administration. * Subjects with some current or prior heart conditions * Subjects taking medications that are known to prolong the QT interval may not be eligible * Subjects with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation * Some subjects with some current or prior gastrointestinal or liver diseases * Subjects with inadequate organ function as defined by the protocol
References
Publications (0)
Data not yet available
No reference posted for this study.