Clinical trial · Interventional
HEC169096 in Participants With Advanced Solid Tumors
Phase 1/2 Study of the Highly-selective RET Inhibitor,HEC169096 in Participants With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors
NCT05451602CI-TRIAL-00109598recruitingPhase 1 / Phase 2ClinicalTrials.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)
An Open, Multi-Center Phase I/II Clinical Study To Evaluate The Safety, Tolerability, Pharmacokinetic Characteristics And Effectiveness Of HEC169096 In Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other 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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HEC169096 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HEC169096
- description
- Multiple doses of HEC169096
- interventionNames
- Drug: HEC169096
Primary outcomes (2)
- measure
- Phase 1: MTD and RP2D of HEC169096
- timeFrame
- Cycle 1 (28 days) of treatment for MTD and at the end of every 2 cycle for RP2D for approximately 12 months or earlier if participant terminates from the study
- description
- Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of HEC169096
- measure
- Phase 2: Overall Response Rate
- timeFrame
- through study completion, an average of 1 year
- description
- As assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Phase 1:Pathologically documented, definitively diagnosed non-resectable advanced solid tumor. * Phase 2: All participants must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor. * Participants has Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2. * Measurable or non-measurable disease as determined by RECIST 1.1; * Adequate hematologic, hepatic and renal function; * Life expectancy of at least 12 weeks; * Negative pregnancy test (urine or serum) for female patients of childbearing potential; * Participants agrees to provide tumor tissue (archived, if available or a fresh biopsy). Exclusion Criteria: * Participant's cancer has a known primary driver alteration other than RET. * Nitrosourea, anthracyclines and mitomycin chemotherapy within 6 weeks prior to study treatment; * Chemotherapy, immunotherapy, radiotherapy, or major surgery within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment; * Those who have received more than 30% of bone marrow radiation or wide-range radiotherapy within 4 weeks before the first study drug treatment (the patients receiving palliative radiotherapy are within 2 weeks before receiving study drug treatment); * Had received traditional Chinese medicine for anti-tumor within a week before receiving study drug treatment; * Had received live vaccine within 4 weeks prior to study treatment; * Had received any investigational agent from other clinical study within 4 weeks or 5 half-lives (whichever is longer) prior to study treatment or are currently participating in other clinical trials; * Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 at the time of starting study treatment . * Central nervous system (CNS) metastases or a primary CNS tumor that is associated with progressive neurological symptoms. * Patients with other malignant tumors within 5 years before the first use of drugs * Patients have a history of severe cardiovascular disease; * Active hepatitis (Hepatitis B: HBsAg-positive and HBV-DNA ≥ 2000 IU/ mL or ≥ 10\^4 cps/ mL; Hepatitis B: HCV antibody-positive and HCV-RNA positive), HIV antibody-positive. * Patients with clinically active interstitial lung disease, active pneumonia, and radiation pneumonia requiring treatment; * Poorly controlled pleural effusion, abdominal effusion, or pericardial effusion after intervention (such as drainage); * Clinically significant active malabsorption syndrome or other diseases that may affect study drug administration and gastrointestinal absorption; * Patients have been treated with any strong CYP3A inhibitors or inducers within 2 weeks prior to the first dose or PPIs in the first week before the first dose.
References
Publications (0)
Data not yet available
No reference posted for this study.