Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • IN10028

    Drug

    The starting dose of IN10028 is 25 mg, with a total of 5 planned dose cohorts: 25 mg, 50 mg, 100 mg, 200 mg and 300 mg, administered orally once daily (QD) continuously with a cycle of 21 days.

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: IN10028Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To explore the incidence of dose-limiting toxicities (DLTs) of IN10028, identify the maximum tolerated dose (MTD), and determine the recommended phase 2 dose (RP2D).

To evaluate the safety and tolerability of IN10028 in patients with advanced malignant solid tumors, characterize the incidence of dose limiting toxicities (DLTs), identify the maximum tolerated dose (MTD), and determine the recommended phase 2 dose (RP2D).

Time frame
Approximately 6 months

Secondary outcomes

1

PK:AUC0-24h of IN10028

To evaluate area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24h) profile following single- and multiple-dose administration of IN10028.

Time frame
Approximately 6 months
2

PK: AUC0-t of IN10028

To evaluate the area under the plasma concentration-time curve from 0 to the last measurable time point (AUC₀-t) profile following single- and multiple-dose administration of IN10028.

Time frame
Approximately 6 months
3

PK: AUC0-∞ of IN10028

To evaluate area under the plasma concentration-time curve from time 0 to infinity (AUC₀-∞) profile following single-dose and multiple-dose dosing of IN10028.

Time frame
Approximately 6 months
4

PK: AUCextrap(%) of IN10028

To evaluate percent of aucinf attributed to extrapolation (AUCextrap(%) )profile following single-dose and multiple-dose administration of IN10028.

Time frame
Approximately 6 months

Other outcomes

Sponsors and contacts

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

InxMed (Shanghai) Co., Ltd.

Lead sponsor

InxMed (Nanjing) Co., Ltd.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: