Clinical trial · Interventional
Clinical Trial to Determine the MTD of HM781-36B in Patients With Advanced Solid Tumors
Phase Ⅰ Study to Determine the Maximum Tolerated Dose of HM781-36B Continuously Given in Patients With Advanced Solid Tumors and to Assess the Food Effect on Pharmacokinetic Profile
NCT01455584CI-TRIAL-00010390completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The main objective of this study is to determine the maximum tolerated dose (MTD) of HM781-36B continuously.
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 |
|---|---|---|---|
| Advanced Solid Malignancies | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HM781-36B tablets | Drug | Poziotinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HM781-36B
- description
- HM781-36B
- interventionNames
- Drug: HM781-36B tablets
Primary outcomes (1)
- measure
- MTD determination
- timeFrame
- Dose limiting Toxicity will be evaluated on Day 28 during Cycle 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically or cytologically confirmed advanced solid tumor 2. Patients who have experienced progressive disease despite of conventional anticancer therapy. Patients who cannot expect effective treatment or prolonged survival with conventional anticancer therapy 3. Previous chemotherapy, radiotherapy and surgical operation are allowed if they are discontinued for at least 4 weeks prior to D0 and all adverse events are resolved 4. Aged ≥19 5. Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2 6. A life expectancy greater than 12 weeks 7. Adequate bone marrow, renal and liver function. 8. Subjects must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures Exclusion Criteria: 1. Patients with hematopoietic malignancies,uncontrolled infection, CNS metastasis. 2. Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are candidates for planned HSCT 3. Patients who have GI malabsorption or difficulty taking oral medication 4. Patients who have psychiatric or congenital disorder 5. Subjects who, in the investigator's opinion, cannot be treated per protocol due to functional impairments 6. Pregnant or breast-feeding patients; Women of childbearing potential without adequate contraception (Men must use adequate contraception.)
References
Publications (0)
Data not yet available
No reference posted for this study.