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.
Participants should be able to understand and voluntarily sign a written ICF (before participating in any trial-related procedures of this study).
Participants are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other specified study procedures.
At the time of signing the ICF: aged between 18 and 75 years (inclusive). If the legal age of consent in the jurisdiction in which the study is taking place is > 18 years, then the legal age of consent should be reached.
Central or local test results are required to confirm the presence of eligible PIK3CA mutations in tumor tissue or blood samples. Eligible PIK3CA mutations include: R88Q, G106A/D/R/S/V, K111N/R/E, G118D, N345D/H/I/K/S/T/Y, C420R, E453A/D/G/K/Q/V, E542A/D/G/K/Q/R/V, E545A/D/G/K/L/Q/R/V, Q546E/H/K/L/P/R, T1025A/I/S, M1043I/T/V, N1044H/I/K/S/T/Y, H1047D/I/L/N/P/Q/R/T/Y, G1049A/C/D/R/S, or other pathogenic PIK3CA mutations.
Any active malignancy ≤ 2 years prior to the first dose of GenSci145, except for the cancer under study and any locally recurrent cancers that have been cured (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical carcinoma in situ, or breast carcinoma in situ)
The disease is stable for at least 3 months, with no progressive disease as confirmed by imaging examination within 4 weeks prior to the first dose of the study treatment, and all neurological symptoms have recovered to baseline;
Treatment with radiation, surgery, or steroids has been discontinued for at least 4 weeks prior to the first dose of study treatment.
Herbal medicines or Chinese patent medicines with anti-tumor activity within 2 weeks;
Single group
GenSci145 tablets
DrugParticipants will receive GenSci145 as stipulated in the research protocol
Phase Ia :Incidence and severity of treatment-emergent adverse events (TEAEs)
Part1:Dose limiting toxicities(DLTs)
To determine the maximum tolerated dose (MTD) (if applicable) and recommended dose for expansion (RDE) of GenSci145.
Peak concentration (Cmax) of GenSci145
Peak time (Tmax) of GenSci145
The area under the drug-time curve from time 0 to the last measurable concentration time point (AUC0-last) of GenSci145
DOR,from the first assessment of CR or PR to the first assessment of disease progression (PD) or death The duration of (whichever occurs first).
DCR,the proportion of subjects whose BOR reached CR, PR or disease stability (SD).
CBR,the proportion of subjects whose BOR reached CR, PR or SD (duration ≥6 months).
TTR,the time from the first treatment to the first assessment of CR or PR.
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