GenSci145 as Monotherapy or in Combination Therapy, in Participants With PIK3CA-mutated, Locally … (NCT07407504) | Clinical Trial Compass
Not Yet RecruitingPhase 1
GenSci145 as Monotherapy or in Combination Therapy, in Participants With PIK3CA-mutated, Locally Advanced or Metastatic Solid Tumors.
China186 participantsStarted 2026-03-14
Plain-language summary
An international, multicenter, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics, and efficacy of GenSci145, as monotherapy or in combination therapy, in participants with PIK3CA-mutated, locally advanced or metastatic solid tumors.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed locally advanced or metastatic solid tumors.
✓. Disease progression after standard therapy, or, in the opinion of the investigator, no available and effective standard therapy.
✓. Histologically or cytologically confirmed HR+/HER2- locally advanced or metastatic breast cancer \[HR+ is defined as estrogen receptor (ER) positive and/or progesterone receptor (PR) positive (≥10% of tumor cell nuclei showing positive staining); HER2- is defined as immunohistochemistry (IHC) 0 or 1+, or IHC 2+ with a negative in situ hybridization (ISH) result\].
✓. Disease progression after standard therapy, or, in the opinion of the investigator, no available and effective standard therapy.
✓. Histologically or cytologically confirmed HR+/HER2- locally advanced or metastatic breast cancer.
✓. Patients must meet one of the following:
✓. Disease progression during (neo)adjuvant endocrine therapy or within 12 months after completion of such therapy, without having received any prior therapy for metastatic disease.
✓. Disease progression occurring more than 12 months after completion of adjuvant endocrine therapy, followed by first-line endocrine therapy for metastatic disease, with subsequent progression on that therapy.
Exclusion criteria
✕. Disease stable for at least 3 months, with no evidence of progression on imaging within 4 weeks prior to first dose of study treatment, all neurologic symptoms recovered to baseline, and no evidence of new or enlarging brain metastases.
What they're measuring
1
Phase Ia :Incidence and severity of treatment-emergent adverse events (TEAEs)
Timeframe: Collect the adverse events (AES) that occurred in the subjects from the signing of the ICF to 30 days after the last administration of the investigational drug or the initiation of a new anti-tumor treatment (whichever occurs first).
2
Part1:Dose limiting toxicities(DLTs)
Timeframe: At the end of Cycle 1 (each cycle is 28 days).
✕. At least 4 weeks have elapsed since completion of CNS-directed radiotherapy, surgery, or corticosteroid therapy prior to the first dose of study treatment.
✕. Myocardial infarction or unstable angina within 6 months prior to the first dose of GenSci145.
✕. New York Heart Association (NYHA) Class III or higher within 4 weeks prior to the first dose.
✕. Left ventricular ejection fraction (LVEF) \<50%, assessed by echocardiogram within 4 weeks prior to the first dose.
✕. Based on three consecutive resting ECGs collected during the screening, the average QT interval corrected by Fridericia's formula (QTcF) is \>450 ms for males and \>470 ms for females.
✕. history of long QT syndrome).
✕. Any clinically significant cardiac rhythm, conduction, or resting ECG abnormality (e.g., complete left bundle branch block, second- or third-degree atrioventricular block).