Clinical trial · Interventional
Study of Theliatinib (HMPL-309) in Patients With Advanced Solid Tumor
Open-label, Dose Escalation Phase I Study of Theliatinib (HMPL-309,Xiliertinib) in Patients With Advanced Solid Tumors
NCT02601274CI-TRIAL-00037256HMPL-309terminatedPhase 1ClinicalTrials.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 change of clinical development plan
Summary
Brief summary (as posted)
A Phase I, open-label, multicenter dose-escalation study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumor activity of hmpl-309 in patients with advanced solid tumors
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Theliatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Group Assignment
- description
- Theliatinib investigational product once a day (QD) will be orally administrated on a 28-day cycle There are 7 dose cohorts,including120mg/160mg/200mg/220mg/300mg/400mg/500mg, QD in the dose escalation stage .
- interventionNames
- Drug: Theliatinib
Primary outcomes (1)
- measure
- incidence of all types/grades of adverse events
- timeFrame
- from first patient in till 30 days after the last patient last visit
- description
- for each patient, adverse events are collected from the date of consent until 30 days after trial discontinuation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathology confirmed solid tumors * Failed to standard treatment or no standard treatments for uncontrolled, recurrent and/or metastatic advance tumor (whatever previous surgery conditions) Dose-escalation stage: \<300mg/day cohort no requiremnet for pathological pattern \>300mg/day cohort required NCSLC, head and net squamous carcinoma, or oesophageal carcinoma Dose-expansion stage required oesophageal carcinoma * Age 18-75 * performance status of 0, or 1, and no worse within 7days * Life expected \>3 months * written informed consent form voluntarily Exclusion Criteria: * Lab testing within 1 week before enrolled, hemoglobin \<9 g/dL or , platelet count \< 750,000/mm3 and\<150000/mm3, * Total bilirubin≥1.5× the upper limit of normal, * Serum creatinine higher than normal range * Diastolic pressure≥150mmHg or systolic pressure≥100mmHg whatever anti-hypertension drug used, * Serum potassium (whenever potassium implemented) , serum calcium(ionic or albumin-type calcium) or serum magnesium outside normal ranges(whenever implemented) * Within previous 4 weeks treated by systemic anti-tumor therapy, or radiotherapy, immune therapy, biological or hormonal therapy, and clinical trials. But exclude the below therapy, Prostate cancer treated by hormonal therapy such as GnRH(gonadotropin-releasing hormone) analogue or antagonist Hormone replacement therapy or oral contraceptive Palliative radiotherapy for bone metastasis within 2 weeks * Prior documental evidence of resistance to EGFR-TKI (epidermal growth factor receptor-tyrosine kinase inhibitors) * Unrecovered from any previous therapy related toxicity to≤ CTCAE(Common Toxicity Criteria for Adverse Effects) 0 or 1or unrecovered from any previous surgery * Any CNS(central nervous system) metastasis with uncontrolled symptoms * Known dysphagia or drug malabsorption * Active infections such as acute pneumonia, hepatitis B active period * APTT (activated partial thromboplastin time) and/or INR(international normalized ratio), PT≥2 the upper limit of normal(not including patients treated by anticoagulation treatment) * ocular surface diseases or dry eye syndrome * skin disease with obvious symptoms and signs * significant cardiovascular disease, including II-IV atrioventricular block, acute myocardial infarction within 6 months, significant angina or Coronary artery bypass graft * Known existing interstitial lung disease * Female patients who are pregnant or feeding, or childbearing potential patient with pregnant testing positive * Any abnormal of clinical and laboratory so that patients unsuitable to attend the trial sine in the opinion of the investigator * Patients unable to comply with the protocol since significant psychological or psychogenic abnormal
References
Publications (0)
Data not yet available
No reference posted for this study.