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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
HEC169096
DrugMultiple doses of HEC169096 during Phase 2；Oral dose of HEC169096 as determined during Phase 2.
Treatment groups
456 Participants
are divided into 1 treatment groupGroup A: HEC169096Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Phase 1: MTD and RP2D of HEC169096
Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of HEC169096
Time frame
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 study2
Phase 2: Overall Response Rate
As assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Time frame
through study completion, an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov