FAK Inhibitor in Patients With Advanced Solid Tumors (NCT07596381) | Clinical Trial Compass
Not Yet RecruitingPhase 1
FAK Inhibitor in Patients With Advanced Solid Tumors
China75 participantsStarted 2026-05-30
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* Subjects must have at least one measurable tumor lesion per RECIST v1.1. Previously irradiated lesions should not be selected as target lesions, unless such irradiated lesion is the only measurable lesion and has documented radiological disease progression, and may then be selected as a target lesion.
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
* Subjects have an estimated expected survival time of at least 3 months.
* Has adequate organ function.
* Urine protein negative or trace (±); or urine protein 1+, but urine protein to creatinine ratio (UPCR) of random morning urine \< 0.5, or 24-hour urine protein quantitation \< 0.5 g/24 h.
* Fema…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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).