FAK Inhibitor in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorInxMed (Shanghai) Co., Ltd.
About this trial
This is A Phase I/Ib Study，aimed to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Efficacy of Focal Adhesion Kinase Inhibitor IN10028 as Monotherapy and Combination Therapy in Patients with Advanced Solid Tumors.
Eligibility criteria
Qualifiers
Able to understand and voluntarily sign the written Informed Consent Form (ICF), which must be signed prior to conducting the study-specific procedures required by the trial.
At the time of signing the ICF, subjects are aged 18 to 75 years, inclusive, male and female.
Subjects must have a histologically or cytologically confirmed diagnosis of advanced or metastatic malignant solid tumor.Monotherapy dose-escalation and dose expansion: Patients with solid tumors who failed prior standard systemic therapy, have no standard treatment options, or are intolerant to standard regimens.
Prior systemic antitumor therapy must be completed at least 3 weeks before the first study drug treatment; prior small molecule TKIs or oral fluoropyrimidines require a minimum 2-week washout period.
Disqualifiers
Subjects unable to receive oral administration or with conditions that severely affect drug digestion and absorption (e.g., subtotal gastrectomy or duodenectomy, severe sinus tract affecting digestion and absorption, and other related diseases.
Subjects with known central nervous system (CNS) metastases, excluding those with asymptomatic CNS metastases or asymptomatic brain metastases following prior treatment, provided that the lesions have been confirmed to be stable for more than 3 months by computed tomography (CT) or magnetic resonance imaging (MRI), and no steroid therapy has been required for at least 4 weeks.
Subjects with known hypersensitivity to any components of the study drug or its analogues.
Subjects with prior treatment of focal adhesion kinase inhibitors (FAKi).
Trial design
Treatments tested in this trial
- IN10028
Treatment groups
75 Participants
are divided into 1 treatment groupSponsors and collaborators
InxMed (Shanghai) Co., Ltd.
Lead sponsor
InxMed (Nanjing) Co., Ltd.
Collaborator
Source ClinicalTrials.gov