HEC169096 in Participants With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunshine Lake Pharma Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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);
Trial design
Treatments tested in this trial
- HEC169096
Treatment groups
456 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov