HEC169096 in Participants With Advanced Solid Tumors (NCT05451602) | Clinical Trial Compass
RecruitingPhase 1/2
HEC169096 in Participants With Advanced Solid Tumors
China456 participantsStarted 2022-10-21
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
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
2
Phase 2: Overall Response Rate
Timeframe: through study completion, an average of 1 year