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GenSci145 as Monotherapy or in Combination Therapy, in Participants With PIK3CA-mutated, Locally Advanced or Metastatic Solid Tumors.

ConditionLocally Advanced or Metastatic Solid Tumors With PIK3CA-mutated
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChangchun GeneScience Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand and voluntarily provide written ICF.

Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other protocol-specified procedures.

Age 18-75 years (inclusive) at the time of providing informed consent.

Histologically or cytologically confirmed locally advanced or metastatic solid tumors.

Disqualifiers

History of any active malignancy within ≤2 years prior to the first dose of GenSci145, except for the malignancy under investigation in this study and any curatively treated locally recurrent malignancies

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.

At least 4 weeks have elapsed since completion of CNS-directed radiotherapy, surgery, or corticosteroid therapy prior to the first dose of study treatment.

History of leptomeningeal metastases, spinal cord compression, or leptomeningeal disease.

Trial design

Design model

Single group

Treatments tested in this trial

  • GenSci145 tablets

    Drug

    Participants will receive GenSci145 as stipulated in the research protocol

Treatment groups

186 Participants
are divided into 1 treatment group
Group A: GenSci145 tabletsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Phase Ia :Incidence and severity of treatment-emergent adverse events (TEAEs)

Time frame
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)

Time frame
At the end of Cycle 1 (each cycle is 28 days).

Secondary outcomes

1

To determine the maximum tolerated dose (MTD) (if applicable) and recommended dose for expansion (RDE) of GenSci145.

Time frame
Approximately form time of first dose of GenSci145 up to 12 months.
2

Peak concentration (Cmax) of GenSci145

Time frame
Approximately 12 months.
3

Peak time (Tmax) of GenSci145

Time frame
Approximately 12 months.
4

The area under the drug-time curve from time 0 to the last measurable concentration time point (AUC0-last) of GenSci145

Time frame
Approximately 12 months.

Other outcomes

1

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).

Time frame
Approximately 12 months.
2

DCR,the proportion of subjects whose BOR reached CR, PR or disease stability (SD).

Time frame
Approximately 12 months.
3

CBR,the proportion of subjects whose BOR reached CR, PR or SD (duration ≥6 months).

Time frame
Approximately 12 months.
4

TTR,the time from the first treatment to the first assessment of CR or PR.

Time frame
Approximately 12 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Changchun GeneScience Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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